From the AGA Journals

Findings on intestinal ultrasound (IUS) are useful for predicting remission in recent-onset Crohn’s disease (CD), a prospective, population-based cohort of newly diagnosed patients in Denmark reported.

Adding to the growing body of evidence on the utility of this noninvasive imaging tool in monitoring disease activity in the newly diagnosed, the multicenter study published in Clinical Gastroenterology and Hepatology characterized ultrasonographic features at diagnosis and evaluated IUS’s prognostic value. Existing literature has focused on patients with long-standing disease.

Investigators led by first author Gorm R. Madsen, MD, PhD, of the Copenhagen Center for Inflammatory Bowel Disease in Children, Adolescents and Adults at Copenhagen University Hospital, observed continued improvement in most IUS parameters throughout the first year. “Our findings thereby emphasize the role of IUS in improving patient management, and its use in patient risk stratification already at diagnosis,” the investigators wrote.

Some 38% of patients reached ultrasonic transmural remission within 3 months of diagnosis, an achievement associated with higher rates of sustained steroid-free clinical remission and reduced need for treatment escalation.

“Ultrasonic transmural remission is achievable early in Crohn’s disease and is associated with favorable outcomes, underscoring the value of intestinal ultrasound in early disease management,” the researchers wrote.

 

Study Details

While IUS is increasingly recognized for monitoring CD, little was known about its prognostic value early in the disease course. “We aimed to determine whether sonographic inflammation at diagnosis — and particularly the achievement pftransmural remission after 3 months — could predict future outcomes,” Madsen told GI & Hepatology News. “This is important, as early identification of patients at risk of surgery or treatment escalation may help guide therapy decisions more effectively.”

From May 2021 to April 2023, 201 patients (mean age, 35 years; 54.2% men) with new adult-onset CD were followed by IUS and monitored with symptomatic, biochemical, and endoscopic evaluations.

After 3 months, transmural remission was achieved more often by patients with colonic disease, and no associations were found between sonographic inflammation at diagnosis and diagnostic delay.

“We were positively surprised. Nearly 40% of newly diagnosed Crohn’s patients achieved transmural remission within 3 months — a higher proportion than seen in earlier studies, which mostly focused on long-standing or trial-selected populations,” Madsen said. “It was also striking how strongly early IUS findings predicted the need for surgery, outperforming endoscopy and biomarkers.”

In other findings, transmural remission at 3 months was significantly associated with steroid-free clinical remission at both 3 months and all subsequent follow-ups within the first year. It was also linked to a lower risk for treatment escalation during the follow-up through to 12 months: 26% vs 53% (P =.003). At 12 months, 41% had achieved transmural remission.

Higher baseline body mass index significantly reduced the likelihood of 12-month transmural remission. For overweight, the odds ratio (OR) was 0.34 (95% CI, 0.12-0.94), while for obesity, the OR was 0.16 (95% CI, 0.04-0.73).

The International Bowel Ultrasound Segmental Activity Score in the terminal ileum at diagnosis emerged as the best predictor of ileocecal resection during the first year, with an optimal threshold of 63 (area under the curve, 0.92; sensitivity, 100%; specificity, 73%).

The use of IUS has expanded considerably in the past 3 years, and in 2024, the American Gastroenterological Association updated its clinical practice guidance on the role of this modality in inflammatory bowel disease.

IUS is noninvasive, radiation-free, inexpensive, and doable at the bedside with immediate results, Madsen said. “For patients, this means less anxiety and discomfort. For healthcare systems, it enables faster clinical decisions, reduced need for endoscopy or MRI, and closer disease monitoring, particularly valuable in treat-to-target strategies.”

In terms of limitations, however, IUS is operator-dependent and consistent training is crucial, he added. “Certain anatomical regions, particularly the proximal small bowel, can be more challenging to evaluate. Additionally, while IUS is highly effective for assessing inflammatory activity, it becomes more difficult to accurately assess disease involvement when inflammation extends beyond approximately 20 cm of the small bowel.”

 

Key Insights

Commenting on the Danish study from a US perspective, Anna L. Silverman, MD, a gastroenterology fellow at Icahn School of Medicine at Mount Sinai in New York City, agreed the findings in adult patients with newly diagnosed, rather than long-standing, CD contribute to the growing body of evidence supporting IUS’s applicability for both treatment monitoring and prognosis.

“By focusing on early-stage CD, the study provides clearer insights into initial disease activity and response to therapy, reinforcing the value of this noninvasive, point-of-care modality,” she told GI & Hepatology News. “These findings enhance our understanding of IUS as a tool to help guide early management decisions in CD.”

Ashwin Ananthakrishnan, MBBS, MPH, AGAF, director of the Crohn’s and Colitis Center at Massachusetts General Hospital and an associate professor at Harvard Medical School, both in Boston, concurred that this is an important study. “It includes newly diagnosed patients — so a very ‘clean’ cohort in terms of not being influenced by confounders,” he told GI & Hepatology News.

“We don’t fully know yet the best treatment target in CD, and this study highlights the importance of early transmural healing in determining outcomes at 1 year,” he noted. In addition, the study highlighted a convenient tool that can increasingly be applied at point of care in the United States. “Colonoscopy at 3 months is not practical and has low patient acceptability, so using IUS in this circumstance would have value and impact.”

Ananthakrishnan pointed to several unanswered questions, however. “Are there patients who may not have healing early but may take some extra time to achieve transmural remission, and if so, what are their outcomes? What is the best timepoint for transmural healing assessment? What is the incremental value of measuring it at 3 vs 6 months?”

In addition, he wondered, how much is the added value of IUS over clinical symptoms and/or markers such as calprotectin and C-reactive protein? “In the subset of patients with clinical and transmural remission, there was no difference in endoscopic outcomes at 1 year, so this is an unanswered question,” Ananthakrishnan said.

This study was funded by an unrestricted grant from the Novo Nordisk Foundation.

Madsen reported receiving a speaker’s fee from Tillotts. Multiple coauthors disclosed having various financial relationships with numerous private-sector companies, including Novo Nordisk. Silverman and Ananthakrishnan reported having no competing interests relevant to their comments.

A version of this article appeared on Medscape.com.

Findings on intestinal ultrasound (IUS) are useful for predicting remission in recent-onset Crohn’s disease (CD), a prospective, population-based cohort of newly diagnosed patients in Denmark reported.

Adding to the growing body of evidence on the utility of this noninvasive imaging tool in monitoring disease activity in the newly diagnosed, the multicenter study published in Clinical Gastroenterology and Hepatology characterized ultrasonographic features at diagnosis and evaluated IUS’s prognostic value. Existing literature has focused on patients with long-standing disease.

Investigators led by first author Gorm R. Madsen, MD, PhD, of the Copenhagen Center for Inflammatory Bowel Disease in Children, Adolescents and Adults at Copenhagen University Hospital, observed continued improvement in most IUS parameters throughout the first year. “Our findings thereby emphasize the role of IUS in improving patient management, and its use in patient risk stratification already at diagnosis,” the investigators wrote.

Some 38% of patients reached ultrasonic transmural remission within 3 months of diagnosis, an achievement associated with higher rates of sustained steroid-free clinical remission and reduced need for treatment escalation.

“Ultrasonic transmural remission is achievable early in Crohn’s disease and is associated with favorable outcomes, underscoring the value of intestinal ultrasound in early disease management,” the researchers wrote.

 

Study Details

While IUS is increasingly recognized for monitoring CD, little was known about its prognostic value early in the disease course. “We aimed to determine whether sonographic inflammation at diagnosis — and particularly the achievement pftransmural remission after 3 months — could predict future outcomes,” Madsen told GI & Hepatology News. “This is important, as early identification of patients at risk of surgery or treatment escalation may help guide therapy decisions more effectively.”

From May 2021 to April 2023, 201 patients (mean age, 35 years; 54.2% men) with new adult-onset CD were followed by IUS and monitored with symptomatic, biochemical, and endoscopic evaluations.

After 3 months, transmural remission was achieved more often by patients with colonic disease, and no associations were found between sonographic inflammation at diagnosis and diagnostic delay.

“We were positively surprised. Nearly 40% of newly diagnosed Crohn’s patients achieved transmural remission within 3 months — a higher proportion than seen in earlier studies, which mostly focused on long-standing or trial-selected populations,” Madsen said. “It was also striking how strongly early IUS findings predicted the need for surgery, outperforming endoscopy and biomarkers.”

In other findings, transmural remission at 3 months was significantly associated with steroid-free clinical remission at both 3 months and all subsequent follow-ups within the first year. It was also linked to a lower risk for treatment escalation during the follow-up through to 12 months: 26% vs 53% (P =.003). At 12 months, 41% had achieved transmural remission.

Higher baseline body mass index significantly reduced the likelihood of 12-month transmural remission. For overweight, the odds ratio (OR) was 0.34 (95% CI, 0.12-0.94), while for obesity, the OR was 0.16 (95% CI, 0.04-0.73).

The International Bowel Ultrasound Segmental Activity Score in the terminal ileum at diagnosis emerged as the best predictor of ileocecal resection during the first year, with an optimal threshold of 63 (area under the curve, 0.92; sensitivity, 100%; specificity, 73%).

The use of IUS has expanded considerably in the past 3 years, and in 2024, the American Gastroenterological Association updated its clinical practice guidance on the role of this modality in inflammatory bowel disease.

IUS is noninvasive, radiation-free, inexpensive, and doable at the bedside with immediate results, Madsen said. “For patients, this means less anxiety and discomfort. For healthcare systems, it enables faster clinical decisions, reduced need for endoscopy or MRI, and closer disease monitoring, particularly valuable in treat-to-target strategies.”

In terms of limitations, however, IUS is operator-dependent and consistent training is crucial, he added. “Certain anatomical regions, particularly the proximal small bowel, can be more challenging to evaluate. Additionally, while IUS is highly effective for assessing inflammatory activity, it becomes more difficult to accurately assess disease involvement when inflammation extends beyond approximately 20 cm of the small bowel.”

 

Key Insights

Commenting on the Danish study from a US perspective, Anna L. Silverman, MD, a gastroenterology fellow at Icahn School of Medicine at Mount Sinai in New York City, agreed the findings in adult patients with newly diagnosed, rather than long-standing, CD contribute to the growing body of evidence supporting IUS’s applicability for both treatment monitoring and prognosis.

“By focusing on early-stage CD, the study provides clearer insights into initial disease activity and response to therapy, reinforcing the value of this noninvasive, point-of-care modality,” she told GI & Hepatology News. “These findings enhance our understanding of IUS as a tool to help guide early management decisions in CD.”

Ashwin Ananthakrishnan, MBBS, MPH, AGAF, director of the Crohn’s and Colitis Center at Massachusetts General Hospital and an associate professor at Harvard Medical School, both in Boston, concurred that this is an important study. “It includes newly diagnosed patients — so a very ‘clean’ cohort in terms of not being influenced by confounders,” he told GI & Hepatology News.

“We don’t fully know yet the best treatment target in CD, and this study highlights the importance of early transmural healing in determining outcomes at 1 year,” he noted. In addition, the study highlighted a convenient tool that can increasingly be applied at point of care in the United States. “Colonoscopy at 3 months is not practical and has low patient acceptability, so using IUS in this circumstance would have value and impact.”

Ananthakrishnan pointed to several unanswered questions, however. “Are there patients who may not have healing early but may take some extra time to achieve transmural remission, and if so, what are their outcomes? What is the best timepoint for transmural healing assessment? What is the incremental value of measuring it at 3 vs 6 months?”

In addition, he wondered, how much is the added value of IUS over clinical symptoms and/or markers such as calprotectin and C-reactive protein? “In the subset of patients with clinical and transmural remission, there was no difference in endoscopic outcomes at 1 year, so this is an unanswered question,” Ananthakrishnan said.

This study was funded by an unrestricted grant from the Novo Nordisk Foundation.

Madsen reported receiving a speaker’s fee from Tillotts. Multiple coauthors disclosed having various financial relationships with numerous private-sector companies, including Novo Nordisk. Silverman and Ananthakrishnan reported having no competing interests relevant to their comments.

A version of this article appeared on Medscape.com.

Findings on intestinal ultrasound (IUS) are useful for predicting remission in recent-onset Crohn’s disease (CD), a prospective, population-based cohort of newly diagnosed patients in Denmark reported.

Adding to the growing body of evidence on the utility of this noninvasive imaging tool in monitoring disease activity in the newly diagnosed, the multicenter study published in Clinical Gastroenterology and Hepatology characterized ultrasonographic features at diagnosis and evaluated IUS’s prognostic value. Existing literature has focused on patients with long-standing disease.

Investigators led by first author Gorm R. Madsen, MD, PhD, of the Copenhagen Center for Inflammatory Bowel Disease in Children, Adolescents and Adults at Copenhagen University Hospital, observed continued improvement in most IUS parameters throughout the first year. “Our findings thereby emphasize the role of IUS in improving patient management, and its use in patient risk stratification already at diagnosis,” the investigators wrote.

Some 38% of patients reached ultrasonic transmural remission within 3 months of diagnosis, an achievement associated with higher rates of sustained steroid-free clinical remission and reduced need for treatment escalation.

“Ultrasonic transmural remission is achievable early in Crohn’s disease and is associated with favorable outcomes, underscoring the value of intestinal ultrasound in early disease management,” the researchers wrote.

 

Study Details

While IUS is increasingly recognized for monitoring CD, little was known about its prognostic value early in the disease course. “We aimed to determine whether sonographic inflammation at diagnosis — and particularly the achievement pftransmural remission after 3 months — could predict future outcomes,” Madsen told GI & Hepatology News. “This is important, as early identification of patients at risk of surgery or treatment escalation may help guide therapy decisions more effectively.”

From May 2021 to April 2023, 201 patients (mean age, 35 years; 54.2% men) with new adult-onset CD were followed by IUS and monitored with symptomatic, biochemical, and endoscopic evaluations.

After 3 months, transmural remission was achieved more often by patients with colonic disease, and no associations were found between sonographic inflammation at diagnosis and diagnostic delay.

“We were positively surprised. Nearly 40% of newly diagnosed Crohn’s patients achieved transmural remission within 3 months — a higher proportion than seen in earlier studies, which mostly focused on long-standing or trial-selected populations,” Madsen said. “It was also striking how strongly early IUS findings predicted the need for surgery, outperforming endoscopy and biomarkers.”

In other findings, transmural remission at 3 months was significantly associated with steroid-free clinical remission at both 3 months and all subsequent follow-ups within the first year. It was also linked to a lower risk for treatment escalation during the follow-up through to 12 months: 26% vs 53% (P =.003). At 12 months, 41% had achieved transmural remission.

Higher baseline body mass index significantly reduced the likelihood of 12-month transmural remission. For overweight, the odds ratio (OR) was 0.34 (95% CI, 0.12-0.94), while for obesity, the OR was 0.16 (95% CI, 0.04-0.73).

The International Bowel Ultrasound Segmental Activity Score in the terminal ileum at diagnosis emerged as the best predictor of ileocecal resection during the first year, with an optimal threshold of 63 (area under the curve, 0.92; sensitivity, 100%; specificity, 73%).

The use of IUS has expanded considerably in the past 3 years, and in 2024, the American Gastroenterological Association updated its clinical practice guidance on the role of this modality in inflammatory bowel disease.

IUS is noninvasive, radiation-free, inexpensive, and doable at the bedside with immediate results, Madsen said. “For patients, this means less anxiety and discomfort. For healthcare systems, it enables faster clinical decisions, reduced need for endoscopy or MRI, and closer disease monitoring, particularly valuable in treat-to-target strategies.”

In terms of limitations, however, IUS is operator-dependent and consistent training is crucial, he added. “Certain anatomical regions, particularly the proximal small bowel, can be more challenging to evaluate. Additionally, while IUS is highly effective for assessing inflammatory activity, it becomes more difficult to accurately assess disease involvement when inflammation extends beyond approximately 20 cm of the small bowel.”

 

Key Insights

Commenting on the Danish study from a US perspective, Anna L. Silverman, MD, a gastroenterology fellow at Icahn School of Medicine at Mount Sinai in New York City, agreed the findings in adult patients with newly diagnosed, rather than long-standing, CD contribute to the growing body of evidence supporting IUS’s applicability for both treatment monitoring and prognosis.

“By focusing on early-stage CD, the study provides clearer insights into initial disease activity and response to therapy, reinforcing the value of this noninvasive, point-of-care modality,” she told GI & Hepatology News. “These findings enhance our understanding of IUS as a tool to help guide early management decisions in CD.”

Ashwin Ananthakrishnan, MBBS, MPH, AGAF, director of the Crohn’s and Colitis Center at Massachusetts General Hospital and an associate professor at Harvard Medical School, both in Boston, concurred that this is an important study. “It includes newly diagnosed patients — so a very ‘clean’ cohort in terms of not being influenced by confounders,” he told GI & Hepatology News.

“We don’t fully know yet the best treatment target in CD, and this study highlights the importance of early transmural healing in determining outcomes at 1 year,” he noted. In addition, the study highlighted a convenient tool that can increasingly be applied at point of care in the United States. “Colonoscopy at 3 months is not practical and has low patient acceptability, so using IUS in this circumstance would have value and impact.”

Ananthakrishnan pointed to several unanswered questions, however. “Are there patients who may not have healing early but may take some extra time to achieve transmural remission, and if so, what are their outcomes? What is the best timepoint for transmural healing assessment? What is the incremental value of measuring it at 3 vs 6 months?”

In addition, he wondered, how much is the added value of IUS over clinical symptoms and/or markers such as calprotectin and C-reactive protein? “In the subset of patients with clinical and transmural remission, there was no difference in endoscopic outcomes at 1 year, so this is an unanswered question,” Ananthakrishnan said.

This study was funded by an unrestricted grant from the Novo Nordisk Foundation.

Madsen reported receiving a speaker’s fee from Tillotts. Multiple coauthors disclosed having various financial relationships with numerous private-sector companies, including Novo Nordisk. Silverman and Ananthakrishnan reported having no competing interests relevant to their comments.

A version of this article appeared on Medscape.com.

The prevalence of eosinophilic esophagitis (EoE) has increased fivefold in the United States since 2009, now affecting about 1 in 700 people and totaling $1.32 billion in annual healthcare costs, according to recent research.

Although EoE has been considered a rare disease, the chronic condition is becoming more common, and healthcare providers should expect to encounter EoE in clinical settings, the study authors wrote.

“Our last assessment of the prevalence and burden of EoE was more than 10 years ago, and we had a strong suspicion we would continue to see increased numbers of patients with EoE and an increasing cost burden related to the condition in the United States,” said senior author Evan S. Dellon, MD, MPH, AGAF, professor of gastroenterology and hepatology and director of the Center for Esophageal Diseases and Swallowing at the University of North Carolina School of Medicine, Chapel Hill, North Carolina.

“EoE is becoming more common,” Dellon said. “Healthcare providers should expect to see EoE in their practices, including in the primary care setting, emergency departments, allergy practices, GI [gastrointestinal] practices, ENT clinics, and endoscopy suites.”

The study was published in Clinical Gastroenterology and Hepatology.

Estimating EoE Prevalence

Dellon and colleagues analyzed the Merative MarketScan Commercial Claims and Encounters and Medicare Fee-for-Service databases to calculate the annual prevalence of EoE, as well as age- and sex-stratified estimates standardized to the US population. They also calculated healthcare utilization, including medications and endoscopic procedures, to estimate annual EoE-associated costs. Since the EoE billing code was introduced in 2008, the analysis included 2009-2022 MarketScan and 2009-2017 Medicare data.

In the MarketScan database, the research team identified 20,435 EoE cases in 2022, with a mean age of 38 years, 16% younger than 18 years, 62% men, and 41% with a comorbid allergic disease code. The most common symptoms and diagnoses were dysphagia (39%), abdominal pain or dyspepsia (24%), and esophageal stricture (19%). Over time, patients also had previous codes for comorbid allergic diseases (64%), dysphagia (62%), or esophageal stricture (32%).

In the Medicare database, the research team identified 1913 EoE cases in 2017, with a mean age of 73 years, 47% men, 90% non-Hispanic White, and 36% with a comorbid allergic disease. The most common symptoms and diagnoses were dysphagia (49%), abdominal pain or dyspepsia (35%), and esophageal stricture (30%). Over time, patients also had codes for comorbid allergic diseases (64%), dysphagia (65%), or esophageal stricture (42%).

The database numbers translated to EoE prevalences of about 163 cases per 100,000 people in MarketScan in 2022 and 64 cases per 100,000 people in Medicare in 2017. Since 2009, there has been a fivefold increase in prevalence in both databases.

In MarketScan, the prevalence was higher among men than among women, at 204 vs 122 cases per 100,000 people. For both sexes, peak prevalence occurred between ages 40 and 44.

In Medicare, prevalence was also higher among men than among women, at 79 vs 55 cases per 100,000 people. Peak prevalence occurred between ages 65 and 69.

Standardized to the US population, EoE prevalence was 142.5 cases per 100,000 people, extrapolating to 472,380 cases. The overall prevalence was approximately 1 in 700, with rates of 1 in 617 for those younger than 65 years and 1 in 1562 for those aged ≥ 65 years.

“The rapidly increasing prevalence year over year for the entire timeframe of the study was surprising, as were our estimates of the total number of EoE patients in the US, which suggests that EoE is no longer a rare disease and is now seen in about 1 in 700 people,” Dellon said. “This almost triples our prior estimates of 1 in 2000 from 10 years ago, with all trends suggesting that the prevalence will continue to increase.”

 

Calculating EoE Costs

In terms of procedures, endoscopy with dilation or biopsy was used in about 60%-70% of patients with EoE in both MarketScan and Medicare during the years analyzed. In addition, upper endoscopy with biopsy was coded in 80%-90% of patients, guidewire-based dilation in 11%-17% of patients, and balloon-based dilation in 13%-20% of patients.

In terms of prescription medications, proton pump inhibitors (41%) and topical steroids (26%) were the most common in MarketScan in 2022, as well as in Medicare in 2017, at 32% and 9%, respectively.

When looking at costs by age and sex, the male cohort with the highest costs was aged 10-14 years, estimated at $106.7 million. Among the female cohort, the highest costs were associated with ages 15-19, estimated at $46.5 million.

Overall, total EoE-associated healthcare costs were estimated to be $1.04 billion in 2017, and when adjusted for inflation, the costs were estimated at $1.32 billion in 2024. This is likely an underestimate, the authors wrote, given that EoE prevalence has likely increased for ages 65 or older since 2017 and for all ages since 2022.

“Researching the prevalence and costs is essential to improving patient care by highlighting the growing burden of this recently recognized and growing chronic disease, guiding policy and insurer decisions, and advocating for better access to effective treatments and support for patients,” said Joy Chang, MD, assistant professor of medicine in the Division of Gastroenterology, University of Michigan, Ann Arbor, Michigan.Chang, who wasn’t involved with this study, specializes in eosinophilic GI diseases and researches patient-physician preferences and decision-making in EoE care.

“Clinicians should remain vigilant for symptoms, utilize guideline-based diagnostic approaches, and consider both medical and dietary treatment strategies to optimize patient outcomes and reduce long-term costs,” she said. “Increased awareness and timely intervention can help mitigate the growing impact of this chronic condition.”

The study was supported by a National Institutes of Health grant and used resources from the University of North Carolina Center for Gastrointestinal Biology and Disease. Dellon reported receiving research funding from and having consultant roles with numerous pharmaceutical companies and organizations. Chang reported having no relevant disclosures.

A version of this article appeared on Medscape.com.

The prevalence of eosinophilic esophagitis (EoE) has increased fivefold in the United States since 2009, now affecting about 1 in 700 people and totaling $1.32 billion in annual healthcare costs, according to recent research.

Although EoE has been considered a rare disease, the chronic condition is becoming more common, and healthcare providers should expect to encounter EoE in clinical settings, the study authors wrote.

“Our last assessment of the prevalence and burden of EoE was more than 10 years ago, and we had a strong suspicion we would continue to see increased numbers of patients with EoE and an increasing cost burden related to the condition in the United States,” said senior author Evan S. Dellon, MD, MPH, AGAF, professor of gastroenterology and hepatology and director of the Center for Esophageal Diseases and Swallowing at the University of North Carolina School of Medicine, Chapel Hill, North Carolina.

“EoE is becoming more common,” Dellon said. “Healthcare providers should expect to see EoE in their practices, including in the primary care setting, emergency departments, allergy practices, GI [gastrointestinal] practices, ENT clinics, and endoscopy suites.”

The study was published in Clinical Gastroenterology and Hepatology.

Estimating EoE Prevalence

Dellon and colleagues analyzed the Merative MarketScan Commercial Claims and Encounters and Medicare Fee-for-Service databases to calculate the annual prevalence of EoE, as well as age- and sex-stratified estimates standardized to the US population. They also calculated healthcare utilization, including medications and endoscopic procedures, to estimate annual EoE-associated costs. Since the EoE billing code was introduced in 2008, the analysis included 2009-2022 MarketScan and 2009-2017 Medicare data.

In the MarketScan database, the research team identified 20,435 EoE cases in 2022, with a mean age of 38 years, 16% younger than 18 years, 62% men, and 41% with a comorbid allergic disease code. The most common symptoms and diagnoses were dysphagia (39%), abdominal pain or dyspepsia (24%), and esophageal stricture (19%). Over time, patients also had previous codes for comorbid allergic diseases (64%), dysphagia (62%), or esophageal stricture (32%).

In the Medicare database, the research team identified 1913 EoE cases in 2017, with a mean age of 73 years, 47% men, 90% non-Hispanic White, and 36% with a comorbid allergic disease. The most common symptoms and diagnoses were dysphagia (49%), abdominal pain or dyspepsia (35%), and esophageal stricture (30%). Over time, patients also had codes for comorbid allergic diseases (64%), dysphagia (65%), or esophageal stricture (42%).

The database numbers translated to EoE prevalences of about 163 cases per 100,000 people in MarketScan in 2022 and 64 cases per 100,000 people in Medicare in 2017. Since 2009, there has been a fivefold increase in prevalence in both databases.

In MarketScan, the prevalence was higher among men than among women, at 204 vs 122 cases per 100,000 people. For both sexes, peak prevalence occurred between ages 40 and 44.

In Medicare, prevalence was also higher among men than among women, at 79 vs 55 cases per 100,000 people. Peak prevalence occurred between ages 65 and 69.

Standardized to the US population, EoE prevalence was 142.5 cases per 100,000 people, extrapolating to 472,380 cases. The overall prevalence was approximately 1 in 700, with rates of 1 in 617 for those younger than 65 years and 1 in 1562 for those aged ≥ 65 years.

“The rapidly increasing prevalence year over year for the entire timeframe of the study was surprising, as were our estimates of the total number of EoE patients in the US, which suggests that EoE is no longer a rare disease and is now seen in about 1 in 700 people,” Dellon said. “This almost triples our prior estimates of 1 in 2000 from 10 years ago, with all trends suggesting that the prevalence will continue to increase.”

 

Calculating EoE Costs

In terms of procedures, endoscopy with dilation or biopsy was used in about 60%-70% of patients with EoE in both MarketScan and Medicare during the years analyzed. In addition, upper endoscopy with biopsy was coded in 80%-90% of patients, guidewire-based dilation in 11%-17% of patients, and balloon-based dilation in 13%-20% of patients.

In terms of prescription medications, proton pump inhibitors (41%) and topical steroids (26%) were the most common in MarketScan in 2022, as well as in Medicare in 2017, at 32% and 9%, respectively.

When looking at costs by age and sex, the male cohort with the highest costs was aged 10-14 years, estimated at $106.7 million. Among the female cohort, the highest costs were associated with ages 15-19, estimated at $46.5 million.

Overall, total EoE-associated healthcare costs were estimated to be $1.04 billion in 2017, and when adjusted for inflation, the costs were estimated at $1.32 billion in 2024. This is likely an underestimate, the authors wrote, given that EoE prevalence has likely increased for ages 65 or older since 2017 and for all ages since 2022.

“Researching the prevalence and costs is essential to improving patient care by highlighting the growing burden of this recently recognized and growing chronic disease, guiding policy and insurer decisions, and advocating for better access to effective treatments and support for patients,” said Joy Chang, MD, assistant professor of medicine in the Division of Gastroenterology, University of Michigan, Ann Arbor, Michigan.Chang, who wasn’t involved with this study, specializes in eosinophilic GI diseases and researches patient-physician preferences and decision-making in EoE care.

“Clinicians should remain vigilant for symptoms, utilize guideline-based diagnostic approaches, and consider both medical and dietary treatment strategies to optimize patient outcomes and reduce long-term costs,” she said. “Increased awareness and timely intervention can help mitigate the growing impact of this chronic condition.”

The study was supported by a National Institutes of Health grant and used resources from the University of North Carolina Center for Gastrointestinal Biology and Disease. Dellon reported receiving research funding from and having consultant roles with numerous pharmaceutical companies and organizations. Chang reported having no relevant disclosures.

A version of this article appeared on Medscape.com.

The prevalence of eosinophilic esophagitis (EoE) has increased fivefold in the United States since 2009, now affecting about 1 in 700 people and totaling $1.32 billion in annual healthcare costs, according to recent research.

Although EoE has been considered a rare disease, the chronic condition is becoming more common, and healthcare providers should expect to encounter EoE in clinical settings, the study authors wrote.

“Our last assessment of the prevalence and burden of EoE was more than 10 years ago, and we had a strong suspicion we would continue to see increased numbers of patients with EoE and an increasing cost burden related to the condition in the United States,” said senior author Evan S. Dellon, MD, MPH, AGAF, professor of gastroenterology and hepatology and director of the Center for Esophageal Diseases and Swallowing at the University of North Carolina School of Medicine, Chapel Hill, North Carolina.

“EoE is becoming more common,” Dellon said. “Healthcare providers should expect to see EoE in their practices, including in the primary care setting, emergency departments, allergy practices, GI [gastrointestinal] practices, ENT clinics, and endoscopy suites.”

The study was published in Clinical Gastroenterology and Hepatology.

Estimating EoE Prevalence

Dellon and colleagues analyzed the Merative MarketScan Commercial Claims and Encounters and Medicare Fee-for-Service databases to calculate the annual prevalence of EoE, as well as age- and sex-stratified estimates standardized to the US population. They also calculated healthcare utilization, including medications and endoscopic procedures, to estimate annual EoE-associated costs. Since the EoE billing code was introduced in 2008, the analysis included 2009-2022 MarketScan and 2009-2017 Medicare data.

In the MarketScan database, the research team identified 20,435 EoE cases in 2022, with a mean age of 38 years, 16% younger than 18 years, 62% men, and 41% with a comorbid allergic disease code. The most common symptoms and diagnoses were dysphagia (39%), abdominal pain or dyspepsia (24%), and esophageal stricture (19%). Over time, patients also had previous codes for comorbid allergic diseases (64%), dysphagia (62%), or esophageal stricture (32%).

In the Medicare database, the research team identified 1913 EoE cases in 2017, with a mean age of 73 years, 47% men, 90% non-Hispanic White, and 36% with a comorbid allergic disease. The most common symptoms and diagnoses were dysphagia (49%), abdominal pain or dyspepsia (35%), and esophageal stricture (30%). Over time, patients also had codes for comorbid allergic diseases (64%), dysphagia (65%), or esophageal stricture (42%).

The database numbers translated to EoE prevalences of about 163 cases per 100,000 people in MarketScan in 2022 and 64 cases per 100,000 people in Medicare in 2017. Since 2009, there has been a fivefold increase in prevalence in both databases.

In MarketScan, the prevalence was higher among men than among women, at 204 vs 122 cases per 100,000 people. For both sexes, peak prevalence occurred between ages 40 and 44.

In Medicare, prevalence was also higher among men than among women, at 79 vs 55 cases per 100,000 people. Peak prevalence occurred between ages 65 and 69.

Standardized to the US population, EoE prevalence was 142.5 cases per 100,000 people, extrapolating to 472,380 cases. The overall prevalence was approximately 1 in 700, with rates of 1 in 617 for those younger than 65 years and 1 in 1562 for those aged ≥ 65 years.

“The rapidly increasing prevalence year over year for the entire timeframe of the study was surprising, as were our estimates of the total number of EoE patients in the US, which suggests that EoE is no longer a rare disease and is now seen in about 1 in 700 people,” Dellon said. “This almost triples our prior estimates of 1 in 2000 from 10 years ago, with all trends suggesting that the prevalence will continue to increase.”

 

Calculating EoE Costs

In terms of procedures, endoscopy with dilation or biopsy was used in about 60%-70% of patients with EoE in both MarketScan and Medicare during the years analyzed. In addition, upper endoscopy with biopsy was coded in 80%-90% of patients, guidewire-based dilation in 11%-17% of patients, and balloon-based dilation in 13%-20% of patients.

In terms of prescription medications, proton pump inhibitors (41%) and topical steroids (26%) were the most common in MarketScan in 2022, as well as in Medicare in 2017, at 32% and 9%, respectively.

When looking at costs by age and sex, the male cohort with the highest costs was aged 10-14 years, estimated at $106.7 million. Among the female cohort, the highest costs were associated with ages 15-19, estimated at $46.5 million.

Overall, total EoE-associated healthcare costs were estimated to be $1.04 billion in 2017, and when adjusted for inflation, the costs were estimated at $1.32 billion in 2024. This is likely an underestimate, the authors wrote, given that EoE prevalence has likely increased for ages 65 or older since 2017 and for all ages since 2022.

“Researching the prevalence and costs is essential to improving patient care by highlighting the growing burden of this recently recognized and growing chronic disease, guiding policy and insurer decisions, and advocating for better access to effective treatments and support for patients,” said Joy Chang, MD, assistant professor of medicine in the Division of Gastroenterology, University of Michigan, Ann Arbor, Michigan.Chang, who wasn’t involved with this study, specializes in eosinophilic GI diseases and researches patient-physician preferences and decision-making in EoE care.

“Clinicians should remain vigilant for symptoms, utilize guideline-based diagnostic approaches, and consider both medical and dietary treatment strategies to optimize patient outcomes and reduce long-term costs,” she said. “Increased awareness and timely intervention can help mitigate the growing impact of this chronic condition.”

The study was supported by a National Institutes of Health grant and used resources from the University of North Carolina Center for Gastrointestinal Biology and Disease. Dellon reported receiving research funding from and having consultant roles with numerous pharmaceutical companies and organizations. Chang reported having no relevant disclosures.

A version of this article appeared on Medscape.com.

An experimental study in zebrafish has suggested the decades-old, first-generation antihistamine chlorcyclizine and/or other antihistamines may be a strategy for treating erythropoietic protoporphyria (EPP)-associated liver disease by decreasing hepatic protoporphorin IX (PP-IX) accumulation.

Currently, liver transplantation is the primary treatment for this rare, painful, and life-threatening genetic disease, which is caused by excessive PP-IX accumulation and affects about 4000 people in the United States.

The findings could eventually lead to a simpler treatment that prevent shepatic damage at a much earlier stage, according to researchers led by M. Bishr Omary, MD, PhD, a professor in the Center for Advanced Biotechnology and Medicine and Robert Wood Johnson Medical School at Rutgers University in Piscataway, New Jersey.

Reporting in Cellular and Molecular Gastroenterology and Hepatology, the investigators found that chlorcyclizine reduced PP-IX levels. EPP is caused by mutations leading to deficiency of the enzyme ferrochelatase, which inserts iron into PP-IX to generate heme. The resulting condition is characterized by PP-IX accumulation, skin photosensitivity, cholestasis, and end-stage liver disease. “Despite available drugs that address photosensitivity, the treatment of EPP-related liver disease remains an unmet need,” Omary and colleagues wrote.

 

The Study

In order to trigger PP-IX overproduction and accumulation, the investigators administered delta-aminolevulinic acid and deferoxamine to zebrafish. These freshwater tropical fish share many physiological characteristics with humans and have been used to model human disease and develop drugs. Furthermore, these fish are transparent at the larval stage, allowing quantification and visualization of porphyrin, which is fluorescent.

The researchers had screened some 2500 approved and bioactive compounds and identified chlorcyclizine as a potent PP-IX–lowering agent.

High-throughput compound screening of ALA + DFO-treated zebrafish found that the HH-1 blocker reduced zebrafish liver PP-IX levels. The effect of chlorcyclizine was validated in porphyrin-loaded primary mouse hepatocytes, transgenic mice, and mice fed the porphyrinogenic compound 3,5-diethoxycarbonyl-1,4-dihydrocollidine. 

Plasma and tissue PP-IX were measured by fluorescence; livers were analyzed by histology, immunoblotting, and quantitative polymerase chain reaction.

Chlorcyclizine-treated zebrafish larvae as well as the two types of mice all showed reduced hepatic PP-IX levels compared with controls. While the neurotransmitter played an important role in PP-IX accumulation in porphyrin-stressed hepatocytes, blockading notably decreased PP-IX levels. 

Detailed analysis showed that chlorcyclizine appeared to work through multiple mechanisms, helping the liver clear toxic porphyrin buildup and reducing inflammation. It also decreased the presence of histamine-producing mast cells. The result was less liver injury, decreased porphyrin-triggered protein aggregation and oxidation, and increased clearance of s PP-I in stool.

Interestingly, in both mouse models, chlorcyclizine lowered PP-IX levels in female but not male mice in liver, erythrocytes, and bone marrow. This sex-specific effect appeared to be related to the greater speed at which male murines metabolize the drug, the authors explained in a news release. In rats, for example, the metabolism of chlorcyclizine is 8 times higher in male than in female livers. 

The investigators plan to launch a clinical trial in EPP patients to evaluate the effectiveness of chlorcyclizine for both liver and skin involvement. And a phase 2 trial is already underway testing the antacid cimetidine for treating EPP skin manifestations. It is possible that the different antihistamines may act additively or synergistically.

This work was supported by National Institutes of Health (NIH) grants and the Henry and Mala Dorfman Family Professorship of Pediatric Hematology/Oncology.

Omary is a member of the NIH/National Institute of Diabetes and Digestive and Kidney Diseases Data and Safety Monitoring Board of the Porphyrias Consortium.

A provisional patent application has been submitted for the use of H1-receptor blockers with or without receptor blockers to treat protoporphyrias associated with PP-IX accumulation.
 

An experimental study in zebrafish has suggested the decades-old, first-generation antihistamine chlorcyclizine and/or other antihistamines may be a strategy for treating erythropoietic protoporphyria (EPP)-associated liver disease by decreasing hepatic protoporphorin IX (PP-IX) accumulation.

Currently, liver transplantation is the primary treatment for this rare, painful, and life-threatening genetic disease, which is caused by excessive PP-IX accumulation and affects about 4000 people in the United States.

The findings could eventually lead to a simpler treatment that prevent shepatic damage at a much earlier stage, according to researchers led by M. Bishr Omary, MD, PhD, a professor in the Center for Advanced Biotechnology and Medicine and Robert Wood Johnson Medical School at Rutgers University in Piscataway, New Jersey.

Reporting in Cellular and Molecular Gastroenterology and Hepatology, the investigators found that chlorcyclizine reduced PP-IX levels. EPP is caused by mutations leading to deficiency of the enzyme ferrochelatase, which inserts iron into PP-IX to generate heme. The resulting condition is characterized by PP-IX accumulation, skin photosensitivity, cholestasis, and end-stage liver disease. “Despite available drugs that address photosensitivity, the treatment of EPP-related liver disease remains an unmet need,” Omary and colleagues wrote.

 

The Study

In order to trigger PP-IX overproduction and accumulation, the investigators administered delta-aminolevulinic acid and deferoxamine to zebrafish. These freshwater tropical fish share many physiological characteristics with humans and have been used to model human disease and develop drugs. Furthermore, these fish are transparent at the larval stage, allowing quantification and visualization of porphyrin, which is fluorescent.

The researchers had screened some 2500 approved and bioactive compounds and identified chlorcyclizine as a potent PP-IX–lowering agent.

High-throughput compound screening of ALA + DFO-treated zebrafish found that the HH-1 blocker reduced zebrafish liver PP-IX levels. The effect of chlorcyclizine was validated in porphyrin-loaded primary mouse hepatocytes, transgenic mice, and mice fed the porphyrinogenic compound 3,5-diethoxycarbonyl-1,4-dihydrocollidine. 

Plasma and tissue PP-IX were measured by fluorescence; livers were analyzed by histology, immunoblotting, and quantitative polymerase chain reaction.

Chlorcyclizine-treated zebrafish larvae as well as the two types of mice all showed reduced hepatic PP-IX levels compared with controls. While the neurotransmitter played an important role in PP-IX accumulation in porphyrin-stressed hepatocytes, blockading notably decreased PP-IX levels. 

Detailed analysis showed that chlorcyclizine appeared to work through multiple mechanisms, helping the liver clear toxic porphyrin buildup and reducing inflammation. It also decreased the presence of histamine-producing mast cells. The result was less liver injury, decreased porphyrin-triggered protein aggregation and oxidation, and increased clearance of s PP-I in stool.

Interestingly, in both mouse models, chlorcyclizine lowered PP-IX levels in female but not male mice in liver, erythrocytes, and bone marrow. This sex-specific effect appeared to be related to the greater speed at which male murines metabolize the drug, the authors explained in a news release. In rats, for example, the metabolism of chlorcyclizine is 8 times higher in male than in female livers. 

The investigators plan to launch a clinical trial in EPP patients to evaluate the effectiveness of chlorcyclizine for both liver and skin involvement. And a phase 2 trial is already underway testing the antacid cimetidine for treating EPP skin manifestations. It is possible that the different antihistamines may act additively or synergistically.

This work was supported by National Institutes of Health (NIH) grants and the Henry and Mala Dorfman Family Professorship of Pediatric Hematology/Oncology.

Omary is a member of the NIH/National Institute of Diabetes and Digestive and Kidney Diseases Data and Safety Monitoring Board of the Porphyrias Consortium.

A provisional patent application has been submitted for the use of H1-receptor blockers with or without receptor blockers to treat protoporphyrias associated with PP-IX accumulation.
 

An experimental study in zebrafish has suggested the decades-old, first-generation antihistamine chlorcyclizine and/or other antihistamines may be a strategy for treating erythropoietic protoporphyria (EPP)-associated liver disease by decreasing hepatic protoporphorin IX (PP-IX) accumulation.

Currently, liver transplantation is the primary treatment for this rare, painful, and life-threatening genetic disease, which is caused by excessive PP-IX accumulation and affects about 4000 people in the United States.

The findings could eventually lead to a simpler treatment that prevent shepatic damage at a much earlier stage, according to researchers led by M. Bishr Omary, MD, PhD, a professor in the Center for Advanced Biotechnology and Medicine and Robert Wood Johnson Medical School at Rutgers University in Piscataway, New Jersey.

Reporting in Cellular and Molecular Gastroenterology and Hepatology, the investigators found that chlorcyclizine reduced PP-IX levels. EPP is caused by mutations leading to deficiency of the enzyme ferrochelatase, which inserts iron into PP-IX to generate heme. The resulting condition is characterized by PP-IX accumulation, skin photosensitivity, cholestasis, and end-stage liver disease. “Despite available drugs that address photosensitivity, the treatment of EPP-related liver disease remains an unmet need,” Omary and colleagues wrote.

 

The Study

In order to trigger PP-IX overproduction and accumulation, the investigators administered delta-aminolevulinic acid and deferoxamine to zebrafish. These freshwater tropical fish share many physiological characteristics with humans and have been used to model human disease and develop drugs. Furthermore, these fish are transparent at the larval stage, allowing quantification and visualization of porphyrin, which is fluorescent.

The researchers had screened some 2500 approved and bioactive compounds and identified chlorcyclizine as a potent PP-IX–lowering agent.

High-throughput compound screening of ALA + DFO-treated zebrafish found that the HH-1 blocker reduced zebrafish liver PP-IX levels. The effect of chlorcyclizine was validated in porphyrin-loaded primary mouse hepatocytes, transgenic mice, and mice fed the porphyrinogenic compound 3,5-diethoxycarbonyl-1,4-dihydrocollidine. 

Plasma and tissue PP-IX were measured by fluorescence; livers were analyzed by histology, immunoblotting, and quantitative polymerase chain reaction.

Chlorcyclizine-treated zebrafish larvae as well as the two types of mice all showed reduced hepatic PP-IX levels compared with controls. While the neurotransmitter played an important role in PP-IX accumulation in porphyrin-stressed hepatocytes, blockading notably decreased PP-IX levels. 

Detailed analysis showed that chlorcyclizine appeared to work through multiple mechanisms, helping the liver clear toxic porphyrin buildup and reducing inflammation. It also decreased the presence of histamine-producing mast cells. The result was less liver injury, decreased porphyrin-triggered protein aggregation and oxidation, and increased clearance of s PP-I in stool.

Interestingly, in both mouse models, chlorcyclizine lowered PP-IX levels in female but not male mice in liver, erythrocytes, and bone marrow. This sex-specific effect appeared to be related to the greater speed at which male murines metabolize the drug, the authors explained in a news release. In rats, for example, the metabolism of chlorcyclizine is 8 times higher in male than in female livers. 

The investigators plan to launch a clinical trial in EPP patients to evaluate the effectiveness of chlorcyclizine for both liver and skin involvement. And a phase 2 trial is already underway testing the antacid cimetidine for treating EPP skin manifestations. It is possible that the different antihistamines may act additively or synergistically.

This work was supported by National Institutes of Health (NIH) grants and the Henry and Mala Dorfman Family Professorship of Pediatric Hematology/Oncology.

Omary is a member of the NIH/National Institute of Diabetes and Digestive and Kidney Diseases Data and Safety Monitoring Board of the Porphyrias Consortium.

A provisional patent application has been submitted for the use of H1-receptor blockers with or without receptor blockers to treat protoporphyrias associated with PP-IX accumulation.
 

An irritable bowel syndrome (IBS) elimination diet based on a novel IBS–specific, immunoglobulin G (IgG) was superior to a sham diet for abdominal pain, an 8-center, randomized double-blind controlled trial found.

While elimination diets can provide a personalized approach to dietary therapy, existing studies have had serious methodological issues, noted lead author Prashant Singh, MBBS, of the Division of Gastroenterology and Hepatology, Department of Internal Medicine, Michigan Medicine, Ann Arbor, Mich., and colleagues in Gastroenterology.

For example, previous studies on IgG-based diets used assays developed without determining IBS trigger foods or establishing a 95% confidence interval–based cutoff using a healthy control comparison group.

 

Study Details

From June 2018 to December 2021, 238 IBS patients testing positive for at least one food on 18-food IgG ELISA (enzyme-linked immunosorbent assay) testing and an average daily abdominal pain intensity score of 3.0 to 7.5 on an 11.0-point scale during a 2-week run-in period were randomized for 8 weeks to an experimental antibody-guided diet or to a sham diet. The primary outcome was a 30% decrease in abdominal pain intensity (API) for 2 of the last 4 weeks of treatment.

The overall study population had a mean age of about 40 years, and more than three-quarters were female. The 3 IBS types – constipation-predominant (IBS-C), diarrhea-predominant (IBS-D), and mixed bowel habits-predominant (IBS-M) – accounted for about a third each in both arms.

The experimental diet eliminated foods based on a positive ELISA result. Its sham counterpart had the same number of foods removed as the number of positive-testing food sensitivities, but the foods eliminated in the sham diet had tested negative on the IgG assay.

Participants reported daily abdominal pain intensity, bloating, and stool consistency, and frequency. They also reported dietary compliance and daily medication use.

Of the 238 randomized adults, 223 were included in the modified intention-to-treat analysis. A significantly greater proportion of subjects in the experimental group met the primary outcome than those in the sham group: 59.6% vs 42.1%, P = .02). “This highlights the potential effectiveness of a personalized elimination diet based on a novel IBS-specific IgG assay,” the authors wrote.

Symptom improvement between arms began to separate out at around 2 weeks, suggesting the effect of the experimental diet was relatively rapid in onset, and continued for at least 8 weeks. The durability of response, however, needs to be assessed in future studies “and it is unclear if there is a role for repeat IgG testing to monitor treatment response,” the authors wrote.

Subgroup analysis revealed that a higher proportion of those with IBS-C and IBS-M in the experimental diet group met the primary endpoint vs the sham group: 67.1% vs 35.8% and 66% vs 29.5%, respectively.

Interestingly, more patients in the experimental arm were noncompliant with their diet. “It is possible that subjects found the experimental diet more difficult to comply with compared with the sham diet or that because the experimental diet was more likely to improve symptoms, dietary indiscretion may have been more common in this group (a phenomenon seen with other elimination diets such as gluten-free diet in celiac disease),” the authors wrote.

Adverse events, deemed unrelated to either regimen, were 3 in the experimental arm vs 8 in the sham arm, which had 2 urinary tract infections.

The authors called for a larger, adequately powered study to assess the efficacy of an elimination diet based on this novel immunoglobulin G assay in patients with IBS-C and IBS-M. Future studies should perform detailed adherence assessments using food diaries.

“Mechanisms of how immunoglobulin G-antibody response to food antigen generates symptoms in irritable bowel syndrome are not well understood. Delineating this might provide new insights into food-related irritable bowel syndrome pathophysiology,” they concluded.

This study was funded by Biomerica Inc.

An irritable bowel syndrome (IBS) elimination diet based on a novel IBS–specific, immunoglobulin G (IgG) was superior to a sham diet for abdominal pain, an 8-center, randomized double-blind controlled trial found.

While elimination diets can provide a personalized approach to dietary therapy, existing studies have had serious methodological issues, noted lead author Prashant Singh, MBBS, of the Division of Gastroenterology and Hepatology, Department of Internal Medicine, Michigan Medicine, Ann Arbor, Mich., and colleagues in Gastroenterology.

For example, previous studies on IgG-based diets used assays developed without determining IBS trigger foods or establishing a 95% confidence interval–based cutoff using a healthy control comparison group.

 

Study Details

From June 2018 to December 2021, 238 IBS patients testing positive for at least one food on 18-food IgG ELISA (enzyme-linked immunosorbent assay) testing and an average daily abdominal pain intensity score of 3.0 to 7.5 on an 11.0-point scale during a 2-week run-in period were randomized for 8 weeks to an experimental antibody-guided diet or to a sham diet. The primary outcome was a 30% decrease in abdominal pain intensity (API) for 2 of the last 4 weeks of treatment.

The overall study population had a mean age of about 40 years, and more than three-quarters were female. The 3 IBS types – constipation-predominant (IBS-C), diarrhea-predominant (IBS-D), and mixed bowel habits-predominant (IBS-M) – accounted for about a third each in both arms.

The experimental diet eliminated foods based on a positive ELISA result. Its sham counterpart had the same number of foods removed as the number of positive-testing food sensitivities, but the foods eliminated in the sham diet had tested negative on the IgG assay.

Participants reported daily abdominal pain intensity, bloating, and stool consistency, and frequency. They also reported dietary compliance and daily medication use.

Of the 238 randomized adults, 223 were included in the modified intention-to-treat analysis. A significantly greater proportion of subjects in the experimental group met the primary outcome than those in the sham group: 59.6% vs 42.1%, P = .02). “This highlights the potential effectiveness of a personalized elimination diet based on a novel IBS-specific IgG assay,” the authors wrote.

Symptom improvement between arms began to separate out at around 2 weeks, suggesting the effect of the experimental diet was relatively rapid in onset, and continued for at least 8 weeks. The durability of response, however, needs to be assessed in future studies “and it is unclear if there is a role for repeat IgG testing to monitor treatment response,” the authors wrote.

Subgroup analysis revealed that a higher proportion of those with IBS-C and IBS-M in the experimental diet group met the primary endpoint vs the sham group: 67.1% vs 35.8% and 66% vs 29.5%, respectively.

Interestingly, more patients in the experimental arm were noncompliant with their diet. “It is possible that subjects found the experimental diet more difficult to comply with compared with the sham diet or that because the experimental diet was more likely to improve symptoms, dietary indiscretion may have been more common in this group (a phenomenon seen with other elimination diets such as gluten-free diet in celiac disease),” the authors wrote.

Adverse events, deemed unrelated to either regimen, were 3 in the experimental arm vs 8 in the sham arm, which had 2 urinary tract infections.

The authors called for a larger, adequately powered study to assess the efficacy of an elimination diet based on this novel immunoglobulin G assay in patients with IBS-C and IBS-M. Future studies should perform detailed adherence assessments using food diaries.

“Mechanisms of how immunoglobulin G-antibody response to food antigen generates symptoms in irritable bowel syndrome are not well understood. Delineating this might provide new insights into food-related irritable bowel syndrome pathophysiology,” they concluded.

This study was funded by Biomerica Inc.

An irritable bowel syndrome (IBS) elimination diet based on a novel IBS–specific, immunoglobulin G (IgG) was superior to a sham diet for abdominal pain, an 8-center, randomized double-blind controlled trial found.

While elimination diets can provide a personalized approach to dietary therapy, existing studies have had serious methodological issues, noted lead author Prashant Singh, MBBS, of the Division of Gastroenterology and Hepatology, Department of Internal Medicine, Michigan Medicine, Ann Arbor, Mich., and colleagues in Gastroenterology.

For example, previous studies on IgG-based diets used assays developed without determining IBS trigger foods or establishing a 95% confidence interval–based cutoff using a healthy control comparison group.

 

Study Details

From June 2018 to December 2021, 238 IBS patients testing positive for at least one food on 18-food IgG ELISA (enzyme-linked immunosorbent assay) testing and an average daily abdominal pain intensity score of 3.0 to 7.5 on an 11.0-point scale during a 2-week run-in period were randomized for 8 weeks to an experimental antibody-guided diet or to a sham diet. The primary outcome was a 30% decrease in abdominal pain intensity (API) for 2 of the last 4 weeks of treatment.

The overall study population had a mean age of about 40 years, and more than three-quarters were female. The 3 IBS types – constipation-predominant (IBS-C), diarrhea-predominant (IBS-D), and mixed bowel habits-predominant (IBS-M) – accounted for about a third each in both arms.

The experimental diet eliminated foods based on a positive ELISA result. Its sham counterpart had the same number of foods removed as the number of positive-testing food sensitivities, but the foods eliminated in the sham diet had tested negative on the IgG assay.

Participants reported daily abdominal pain intensity, bloating, and stool consistency, and frequency. They also reported dietary compliance and daily medication use.

Of the 238 randomized adults, 223 were included in the modified intention-to-treat analysis. A significantly greater proportion of subjects in the experimental group met the primary outcome than those in the sham group: 59.6% vs 42.1%, P = .02). “This highlights the potential effectiveness of a personalized elimination diet based on a novel IBS-specific IgG assay,” the authors wrote.

Symptom improvement between arms began to separate out at around 2 weeks, suggesting the effect of the experimental diet was relatively rapid in onset, and continued for at least 8 weeks. The durability of response, however, needs to be assessed in future studies “and it is unclear if there is a role for repeat IgG testing to monitor treatment response,” the authors wrote.

Subgroup analysis revealed that a higher proportion of those with IBS-C and IBS-M in the experimental diet group met the primary endpoint vs the sham group: 67.1% vs 35.8% and 66% vs 29.5%, respectively.

Interestingly, more patients in the experimental arm were noncompliant with their diet. “It is possible that subjects found the experimental diet more difficult to comply with compared with the sham diet or that because the experimental diet was more likely to improve symptoms, dietary indiscretion may have been more common in this group (a phenomenon seen with other elimination diets such as gluten-free diet in celiac disease),” the authors wrote.

Adverse events, deemed unrelated to either regimen, were 3 in the experimental arm vs 8 in the sham arm, which had 2 urinary tract infections.

The authors called for a larger, adequately powered study to assess the efficacy of an elimination diet based on this novel immunoglobulin G assay in patients with IBS-C and IBS-M. Future studies should perform detailed adherence assessments using food diaries.

“Mechanisms of how immunoglobulin G-antibody response to food antigen generates symptoms in irritable bowel syndrome are not well understood. Delineating this might provide new insights into food-related irritable bowel syndrome pathophysiology,” they concluded.

This study was funded by Biomerica Inc.

Clinicians can help reduce gastric cancer incidence and mortality in high-risk groups through endoscopic screening and surveillance of precancerous conditions, such as gastric intestinal metaplasia (GIM), according to a new clinical practice update from AGA.

The update supports additional gastric guidance published so far in 2025, including a clinical guideline on the diagnosis and management of gastric premalignant conditions (GPMC) from the American College of Gastroenterology (ACG) and upper GI endoscopy quality indicators from ACG and the American Society for Gastrointestinal Endoscopy (ASGE).

“The synergy of these three publications coming out at the same time helps us to finally establish surveillance of high-risk gastric conditions in practice, as we do in the colon and esophagus,” said Douglas R. Morgan, MD, professor of medicine in gastroenterology and hepatology and director of Global Health programs in gastroenterology at the University of Alabama at Birmingham.

Morgan, who wasn’t involved with the AGA update, served as lead author for the ACG guideline and co-author of the ACG-ASGE quality indicators. He also co-authored the 2024 ACG clinical guideline on treating Helicobacter pylori infection, which has implications for gastric cancer.

“The AGA and ACG updates provide detail, while the QI document is an enforcer with medical, legal, and reimbursement implications,” he said. “We have an alignment of the stars with this overdue move toward concrete surveillance for high-risk lesions in the stomach.”

The clinical practice update was published in Gastroenterology.

 

Gastric Cancer Screening

Gastric cancer remains a leading cause of preventable cancer and mortality in certain US populations, the authors wrote. The top ways to reduce mortality include primary prevention, particularly by eradicating H pylori, and secondary prevention through screening and surveillance.

High-risk groups in the United States should be considered for gastric cancer screening, including first-generation immigrants from high-incidence regions and potentially other non-White racial and ethnic groups, those with a family history of gastric cancer in a first-degree relative, and those with certain hereditary GI polyposis or hereditary cancer syndromes.

Endoscopy remains the best test for screening or surveillance of high-risk groups, the authors wrote, since it allows for direct visualization to endoscopically stage the mucosa, identify any concerning areas of neoplasia, and enable biopsies. Both endoscopic and histologic staging are key for risk stratification and surveillance decisions.

In particular, clinicians should use a high-definition white light endoscopy system with image enhancement, gastric mucosal cleansing, and insufflation to see the mucosa. As part of this, clinicians should allow for adequate visual inspection time, photodocumentation, and systematic biopsy protocol for mucosal staging, where appropriate.

As part of this, clinicians should consider H pylori eradication as an essential adjunct to endoscopic screening, the authors wrote. Opportunistic screening for H pylori should be considered in high-risk groups, and familial-based testing should be considered among adult household members of patients who test positive for H pylori.

 

Endoscopic Biopsy and Diagnosis

In patients with suspected gastric atrophy — with or without GIM — gastric biopsies should be obtained with a systematic approach, the authors wrote. Clinicians should take a minimum of five biopsies, sampling from the antrum/incisura and corpus.

Endoscopists should work with their pathologists on consistent documentation of histologic risk-stratification parameters when atrophic gastritis is diagnosed, the authors wrote. To inform clinical decision-making, this should include documentation of the presence or absence of H pylori infection, severity of atrophy or metaplasia, and histologic subtyping of GIM.

Although GIM and dysplasia are endoscopically detectable, these findings often go undiagnosed when endoscopists aren’t familiar with the characteristic visual features, the authors wrote. More training is needed, especially in the US, and although artificial intelligence tools appear promising for detecting early gastric neoplasia, data remain too preliminary to recommend routine use, the authors added.

Since indefinite and low-grade dysplasia can be difficult to identify by endoscopy and accurately diagnosis on histopathology, all dysplasia should be confirmed by an experienced gastrointestinal pathologist, the authors wrote. Clinicians should refer patients with visible or nonvisible dysplasia to an endoscopist or center with expertise in gastric neoplasia.

 

Endoscopic Management and Surveillance

If an index screening endoscopy doesn’t identify atrophy, GIM, or neoplasia, ongoing screening should be based on a patient’s risk factors and preferences. If the patient has a family history or multiple risk factors, ongoing screening should be considered. However, the optimal screening intervals in these scenarios aren’t well-defined.

Patients with confirmed gastric atrophy should undergo risk stratification, the authors wrote. Those with severe atrophic gastritis or multifocal/incomplete GIM would likely benefit from endoscopic surveillance, particularly if they have other risk factors such as family history. Surveillance should be considered every 3 years, though shorter intervals may be advisable for those with multiple risk factors such as severe GIM.

Patients with high-grade dysplasia or early gastric cancer should undergo endoscopic submucosal dissection (ESD), with the goal of en bloc, R0 resection to enable accurate pathologic staging and the intent to cure. Eradicating active H pylori infection is essential — but shouldn’t delay endoscopic intervention, the authors wrote.

In addition, patients with a history of successfully resected gastric dysplasia or cancer should undergo endoscopic surveillance. Although post-ESD surveillance intervals have been suggested in other recent AGA clinical practice updates, additional data are needed, particularly for US recommendations, the authors wrote.

Although type 1 gastric carcinoids in patients with atrophic gastritis are typically indolent, especially if less than 1 cm, endoscopists may consider resecting them and should resect lesions between 1and 2 cm. Patients with lesions over 2 cm should undergo cross-sectional imaging and be referred for surgical resection, given the risk for metastasis.

 

Patient-Centered Approach

The guideline authors suggested thinking about screening and surveillance on a patient-level basis. For instance, only those who are fit for endoscopic or potentially surgical treatment should be screened for gastric cancer and continued surveillance of GPMC, they wrote. If a person is no longer fit for endoscopic or surgical treatment, whether due to life expectancy or other comorbidities, then screening should be stopped.

In addition, to achieve health equity, clinicians should take a personalized approach to assess a patient’s risk for gastric cancer and determine whether to pursue screening and surveillance, the authors wrote. Modifiable risk factors — such as tobacco use, high-salt and processed food diets, and lack of health care — should also be addressed, since most of these risk factors disproportionately affect high-risk patients and represent healthcare disparities, they added.

“This update provides clinicians with a framework for understanding the natural history and epidemiology of gastric polyps, as well as guidance on best practices for the endoscopic detection and classification of gastric polyps, best practices for the endoscopic resection of gastric polyps, and best practices for endoscopic surveillance following resection,” said Hashem El-Serag, MD, professor and chair of medicine at the Baylor College of Medicine and director of the Texas Medical Center Digestive Diseases Center in Houston.

El-Serag, who wasn’t involved with the clinical practice update, has researched and published on consensus around the diagnosis and management of GIM.

“Stomach polyps are commonly found during routine endoscopic procedures. They are mostly asymptomatic and incidental, and therefore, clinicians may not be prepared ahead of time on how to deal with them,” he said. “The appropriate management requires proper identification and sampling of the polyp features and the uninvolved gastric mucosa, as well as a clear understanding of the risk factors and prognosis. Recent changes in the epidemiology and endoscopic management of gastric polyps makes this update timely and important.”

The update received no particular funding. The authors disclosed receiving grant support, having consultant relationships with, and serving in advisory roles for numerous pharmaceutical, biomedical, and biotechnology firms. Morgan and El-Serag reported having no relevant disclosures.

A version of this article appeared on Medscape.com.

Clinicians can help reduce gastric cancer incidence and mortality in high-risk groups through endoscopic screening and surveillance of precancerous conditions, such as gastric intestinal metaplasia (GIM), according to a new clinical practice update from AGA.

The update supports additional gastric guidance published so far in 2025, including a clinical guideline on the diagnosis and management of gastric premalignant conditions (GPMC) from the American College of Gastroenterology (ACG) and upper GI endoscopy quality indicators from ACG and the American Society for Gastrointestinal Endoscopy (ASGE).

“The synergy of these three publications coming out at the same time helps us to finally establish surveillance of high-risk gastric conditions in practice, as we do in the colon and esophagus,” said Douglas R. Morgan, MD, professor of medicine in gastroenterology and hepatology and director of Global Health programs in gastroenterology at the University of Alabama at Birmingham.

Morgan, who wasn’t involved with the AGA update, served as lead author for the ACG guideline and co-author of the ACG-ASGE quality indicators. He also co-authored the 2024 ACG clinical guideline on treating Helicobacter pylori infection, which has implications for gastric cancer.

“The AGA and ACG updates provide detail, while the QI document is an enforcer with medical, legal, and reimbursement implications,” he said. “We have an alignment of the stars with this overdue move toward concrete surveillance for high-risk lesions in the stomach.”

The clinical practice update was published in Gastroenterology.

 

Gastric Cancer Screening

Gastric cancer remains a leading cause of preventable cancer and mortality in certain US populations, the authors wrote. The top ways to reduce mortality include primary prevention, particularly by eradicating H pylori, and secondary prevention through screening and surveillance.

High-risk groups in the United States should be considered for gastric cancer screening, including first-generation immigrants from high-incidence regions and potentially other non-White racial and ethnic groups, those with a family history of gastric cancer in a first-degree relative, and those with certain hereditary GI polyposis or hereditary cancer syndromes.

Endoscopy remains the best test for screening or surveillance of high-risk groups, the authors wrote, since it allows for direct visualization to endoscopically stage the mucosa, identify any concerning areas of neoplasia, and enable biopsies. Both endoscopic and histologic staging are key for risk stratification and surveillance decisions.

In particular, clinicians should use a high-definition white light endoscopy system with image enhancement, gastric mucosal cleansing, and insufflation to see the mucosa. As part of this, clinicians should allow for adequate visual inspection time, photodocumentation, and systematic biopsy protocol for mucosal staging, where appropriate.

As part of this, clinicians should consider H pylori eradication as an essential adjunct to endoscopic screening, the authors wrote. Opportunistic screening for H pylori should be considered in high-risk groups, and familial-based testing should be considered among adult household members of patients who test positive for H pylori.

 

Endoscopic Biopsy and Diagnosis

In patients with suspected gastric atrophy — with or without GIM — gastric biopsies should be obtained with a systematic approach, the authors wrote. Clinicians should take a minimum of five biopsies, sampling from the antrum/incisura and corpus.

Endoscopists should work with their pathologists on consistent documentation of histologic risk-stratification parameters when atrophic gastritis is diagnosed, the authors wrote. To inform clinical decision-making, this should include documentation of the presence or absence of H pylori infection, severity of atrophy or metaplasia, and histologic subtyping of GIM.

Although GIM and dysplasia are endoscopically detectable, these findings often go undiagnosed when endoscopists aren’t familiar with the characteristic visual features, the authors wrote. More training is needed, especially in the US, and although artificial intelligence tools appear promising for detecting early gastric neoplasia, data remain too preliminary to recommend routine use, the authors added.

Since indefinite and low-grade dysplasia can be difficult to identify by endoscopy and accurately diagnosis on histopathology, all dysplasia should be confirmed by an experienced gastrointestinal pathologist, the authors wrote. Clinicians should refer patients with visible or nonvisible dysplasia to an endoscopist or center with expertise in gastric neoplasia.

 

Endoscopic Management and Surveillance

If an index screening endoscopy doesn’t identify atrophy, GIM, or neoplasia, ongoing screening should be based on a patient’s risk factors and preferences. If the patient has a family history or multiple risk factors, ongoing screening should be considered. However, the optimal screening intervals in these scenarios aren’t well-defined.

Patients with confirmed gastric atrophy should undergo risk stratification, the authors wrote. Those with severe atrophic gastritis or multifocal/incomplete GIM would likely benefit from endoscopic surveillance, particularly if they have other risk factors such as family history. Surveillance should be considered every 3 years, though shorter intervals may be advisable for those with multiple risk factors such as severe GIM.

Patients with high-grade dysplasia or early gastric cancer should undergo endoscopic submucosal dissection (ESD), with the goal of en bloc, R0 resection to enable accurate pathologic staging and the intent to cure. Eradicating active H pylori infection is essential — but shouldn’t delay endoscopic intervention, the authors wrote.

In addition, patients with a history of successfully resected gastric dysplasia or cancer should undergo endoscopic surveillance. Although post-ESD surveillance intervals have been suggested in other recent AGA clinical practice updates, additional data are needed, particularly for US recommendations, the authors wrote.

Although type 1 gastric carcinoids in patients with atrophic gastritis are typically indolent, especially if less than 1 cm, endoscopists may consider resecting them and should resect lesions between 1and 2 cm. Patients with lesions over 2 cm should undergo cross-sectional imaging and be referred for surgical resection, given the risk for metastasis.

 

Patient-Centered Approach

The guideline authors suggested thinking about screening and surveillance on a patient-level basis. For instance, only those who are fit for endoscopic or potentially surgical treatment should be screened for gastric cancer and continued surveillance of GPMC, they wrote. If a person is no longer fit for endoscopic or surgical treatment, whether due to life expectancy or other comorbidities, then screening should be stopped.

In addition, to achieve health equity, clinicians should take a personalized approach to assess a patient’s risk for gastric cancer and determine whether to pursue screening and surveillance, the authors wrote. Modifiable risk factors — such as tobacco use, high-salt and processed food diets, and lack of health care — should also be addressed, since most of these risk factors disproportionately affect high-risk patients and represent healthcare disparities, they added.

“This update provides clinicians with a framework for understanding the natural history and epidemiology of gastric polyps, as well as guidance on best practices for the endoscopic detection and classification of gastric polyps, best practices for the endoscopic resection of gastric polyps, and best practices for endoscopic surveillance following resection,” said Hashem El-Serag, MD, professor and chair of medicine at the Baylor College of Medicine and director of the Texas Medical Center Digestive Diseases Center in Houston.

El-Serag, who wasn’t involved with the clinical practice update, has researched and published on consensus around the diagnosis and management of GIM.

“Stomach polyps are commonly found during routine endoscopic procedures. They are mostly asymptomatic and incidental, and therefore, clinicians may not be prepared ahead of time on how to deal with them,” he said. “The appropriate management requires proper identification and sampling of the polyp features and the uninvolved gastric mucosa, as well as a clear understanding of the risk factors and prognosis. Recent changes in the epidemiology and endoscopic management of gastric polyps makes this update timely and important.”

The update received no particular funding. The authors disclosed receiving grant support, having consultant relationships with, and serving in advisory roles for numerous pharmaceutical, biomedical, and biotechnology firms. Morgan and El-Serag reported having no relevant disclosures.

A version of this article appeared on Medscape.com.

Clinicians can help reduce gastric cancer incidence and mortality in high-risk groups through endoscopic screening and surveillance of precancerous conditions, such as gastric intestinal metaplasia (GIM), according to a new clinical practice update from AGA.

The update supports additional gastric guidance published so far in 2025, including a clinical guideline on the diagnosis and management of gastric premalignant conditions (GPMC) from the American College of Gastroenterology (ACG) and upper GI endoscopy quality indicators from ACG and the American Society for Gastrointestinal Endoscopy (ASGE).

“The synergy of these three publications coming out at the same time helps us to finally establish surveillance of high-risk gastric conditions in practice, as we do in the colon and esophagus,” said Douglas R. Morgan, MD, professor of medicine in gastroenterology and hepatology and director of Global Health programs in gastroenterology at the University of Alabama at Birmingham.

Morgan, who wasn’t involved with the AGA update, served as lead author for the ACG guideline and co-author of the ACG-ASGE quality indicators. He also co-authored the 2024 ACG clinical guideline on treating Helicobacter pylori infection, which has implications for gastric cancer.

“The AGA and ACG updates provide detail, while the QI document is an enforcer with medical, legal, and reimbursement implications,” he said. “We have an alignment of the stars with this overdue move toward concrete surveillance for high-risk lesions in the stomach.”

The clinical practice update was published in Gastroenterology.

 

Gastric Cancer Screening

Gastric cancer remains a leading cause of preventable cancer and mortality in certain US populations, the authors wrote. The top ways to reduce mortality include primary prevention, particularly by eradicating H pylori, and secondary prevention through screening and surveillance.

High-risk groups in the United States should be considered for gastric cancer screening, including first-generation immigrants from high-incidence regions and potentially other non-White racial and ethnic groups, those with a family history of gastric cancer in a first-degree relative, and those with certain hereditary GI polyposis or hereditary cancer syndromes.

Endoscopy remains the best test for screening or surveillance of high-risk groups, the authors wrote, since it allows for direct visualization to endoscopically stage the mucosa, identify any concerning areas of neoplasia, and enable biopsies. Both endoscopic and histologic staging are key for risk stratification and surveillance decisions.

In particular, clinicians should use a high-definition white light endoscopy system with image enhancement, gastric mucosal cleansing, and insufflation to see the mucosa. As part of this, clinicians should allow for adequate visual inspection time, photodocumentation, and systematic biopsy protocol for mucosal staging, where appropriate.

As part of this, clinicians should consider H pylori eradication as an essential adjunct to endoscopic screening, the authors wrote. Opportunistic screening for H pylori should be considered in high-risk groups, and familial-based testing should be considered among adult household members of patients who test positive for H pylori.

 

Endoscopic Biopsy and Diagnosis

In patients with suspected gastric atrophy — with or without GIM — gastric biopsies should be obtained with a systematic approach, the authors wrote. Clinicians should take a minimum of five biopsies, sampling from the antrum/incisura and corpus.

Endoscopists should work with their pathologists on consistent documentation of histologic risk-stratification parameters when atrophic gastritis is diagnosed, the authors wrote. To inform clinical decision-making, this should include documentation of the presence or absence of H pylori infection, severity of atrophy or metaplasia, and histologic subtyping of GIM.

Although GIM and dysplasia are endoscopically detectable, these findings often go undiagnosed when endoscopists aren’t familiar with the characteristic visual features, the authors wrote. More training is needed, especially in the US, and although artificial intelligence tools appear promising for detecting early gastric neoplasia, data remain too preliminary to recommend routine use, the authors added.

Since indefinite and low-grade dysplasia can be difficult to identify by endoscopy and accurately diagnosis on histopathology, all dysplasia should be confirmed by an experienced gastrointestinal pathologist, the authors wrote. Clinicians should refer patients with visible or nonvisible dysplasia to an endoscopist or center with expertise in gastric neoplasia.

 

Endoscopic Management and Surveillance

If an index screening endoscopy doesn’t identify atrophy, GIM, or neoplasia, ongoing screening should be based on a patient’s risk factors and preferences. If the patient has a family history or multiple risk factors, ongoing screening should be considered. However, the optimal screening intervals in these scenarios aren’t well-defined.

Patients with confirmed gastric atrophy should undergo risk stratification, the authors wrote. Those with severe atrophic gastritis or multifocal/incomplete GIM would likely benefit from endoscopic surveillance, particularly if they have other risk factors such as family history. Surveillance should be considered every 3 years, though shorter intervals may be advisable for those with multiple risk factors such as severe GIM.

Patients with high-grade dysplasia or early gastric cancer should undergo endoscopic submucosal dissection (ESD), with the goal of en bloc, R0 resection to enable accurate pathologic staging and the intent to cure. Eradicating active H pylori infection is essential — but shouldn’t delay endoscopic intervention, the authors wrote.

In addition, patients with a history of successfully resected gastric dysplasia or cancer should undergo endoscopic surveillance. Although post-ESD surveillance intervals have been suggested in other recent AGA clinical practice updates, additional data are needed, particularly for US recommendations, the authors wrote.

Although type 1 gastric carcinoids in patients with atrophic gastritis are typically indolent, especially if less than 1 cm, endoscopists may consider resecting them and should resect lesions between 1and 2 cm. Patients with lesions over 2 cm should undergo cross-sectional imaging and be referred for surgical resection, given the risk for metastasis.

 

Patient-Centered Approach

The guideline authors suggested thinking about screening and surveillance on a patient-level basis. For instance, only those who are fit for endoscopic or potentially surgical treatment should be screened for gastric cancer and continued surveillance of GPMC, they wrote. If a person is no longer fit for endoscopic or surgical treatment, whether due to life expectancy or other comorbidities, then screening should be stopped.

In addition, to achieve health equity, clinicians should take a personalized approach to assess a patient’s risk for gastric cancer and determine whether to pursue screening and surveillance, the authors wrote. Modifiable risk factors — such as tobacco use, high-salt and processed food diets, and lack of health care — should also be addressed, since most of these risk factors disproportionately affect high-risk patients and represent healthcare disparities, they added.

“This update provides clinicians with a framework for understanding the natural history and epidemiology of gastric polyps, as well as guidance on best practices for the endoscopic detection and classification of gastric polyps, best practices for the endoscopic resection of gastric polyps, and best practices for endoscopic surveillance following resection,” said Hashem El-Serag, MD, professor and chair of medicine at the Baylor College of Medicine and director of the Texas Medical Center Digestive Diseases Center in Houston.

El-Serag, who wasn’t involved with the clinical practice update, has researched and published on consensus around the diagnosis and management of GIM.

“Stomach polyps are commonly found during routine endoscopic procedures. They are mostly asymptomatic and incidental, and therefore, clinicians may not be prepared ahead of time on how to deal with them,” he said. “The appropriate management requires proper identification and sampling of the polyp features and the uninvolved gastric mucosa, as well as a clear understanding of the risk factors and prognosis. Recent changes in the epidemiology and endoscopic management of gastric polyps makes this update timely and important.”

The update received no particular funding. The authors disclosed receiving grant support, having consultant relationships with, and serving in advisory roles for numerous pharmaceutical, biomedical, and biotechnology firms. Morgan and El-Serag reported having no relevant disclosures.

A version of this article appeared on Medscape.com.

An AGA multidisciplinary panel has reached the conclusion that no recommendation can be made for or against the use of computer-aided detection (CADe)–assisted colonoscopy for colorectal cancer (CRC), the third most common cause of cancer mortality in the United States.

The systematic data review is a collaboration between AGA and The BMJ’s MAGIC Rapid Recommendations. The BMJ issued a separate recommendation against CADe shortly after the AGA guideline was published.

Led by Shahnaz S. Sultan, MD, MHSc, AGAF, of the Division of Gastroenterology, Hepatology, and Nutrition at University of Minnesota, Minneapolis, and recently published in Gastroenterology, found only very low certainty of GRADE-based evidence for several critical long-term outcomes, both desirable and undesirable. These included the following: 11 fewer CRCs per 10,000 individuals and two fewer CRC deaths per 10,000 individuals, an increased burden of more intensive surveillance colonoscopies (635 more per 10,000 individuals), and cost and resource implications.

This technology did, however, yield an 8% (95% CI, 6-10) absolute increase in the adenoma detection rate (ADR) and a 2% (95% CI, 0-4) increase in the detection rate of advanced adenomas and/or sessile serrated lesions. “How this translates into a reduction in CRC incidence or death is where we were uncertain,” Sultan said. “Our best effort at trying to translate the ADR and other endoscopy outcomes to CRC incidence and CRC death relied on the modeling study, which included a lot of assumptions, which also contributed to our overall lower certainty.”

The systematic and meta-analysis included 41 randomized controlled trials with more than 32,108 participants who underwent CADe-assisted colonoscopy. This technology was associated with a higher polyp detection rate than standard colonoscopy: 56.1% vs 47.9% (relative risk [RR], 1.22, 95% CI, 1.15-1.28). It also had a higher ADR: 44.8% vs 37.4% (RR, 1.22; 95% CI, 1.16-1.29).

But although CADe-assisted colonoscopy may increase ADR, it carries a risk for overdiagnosis, as most polyps detected during colonoscopy are diminutive (< 5 mm) and of low malignant potential, the panel noted. Approximately 25% of lesions are missed at colonoscopy. More than 15 million colonoscopies are performed annually in the United States, but studies have demonstrated variable quality of colonoscopies across key quality indicators.

“Artificial intelligence [AI] is revolutionizing medicine and healthcare in the field of GI [gastroenterology], and CADe in colonoscopy has been brought to commercialization,” Sultan told GI & Hepatology News. “Unlike many areas of endoscopic research where we often have a finite number of clinical trial data, CADe-assisted colonoscopy intervention has been studied in over 44 randomized controlled trials and numerous nonrandomized, real-world studies. The question of whether or not to adopt this intervention at a health system or practice level is an important question that was prioritized to be addressed as guidance was needed.”

Commenting on the guideline but not involved in its formulation, Larry S. Kim, MD, MBA, AGAF, a gastroenterologist at South Denver Gastroenterology in Denver, Colorado, said his practice group has used the GI Genius AI system in its affiliated hospitals but has so far chosen not to implement the technology at its endoscopy centers. “At the hospital, our physicians have the ability to utilize the system for select patients or not at all,” he told GI & Hepatology News.

The fact that The BMJ reached a different conclusion based on the same data, evidence-grading system, and microsimulation, Kim added, “highlights the point that when evidence for benefit is uncertain, underlying values are critical.” In declining to make a recommendation, the AGA panel balanced the benefit of improved detection of potentially precancerous adenomas vs increased resource utilization in the face of unclear benefit. “With different priorities, other bodies could reasonably decide to recommend either for or against CADe.”

 

The Future

According to Sultan, gastroenterologists need a better understanding of patient values and preferences and the value placed on increased adenoma detection, which may also lead to more lifetime colonoscopies without reducing the risk for CRC. “We need better intermediate- and long-term data on the impact of adenoma detection on interval cancers and CRC incidence,” she said. “We need data on detection of polyps that are more clinically significant such as those 6-10 mm in size, as well as serrated sessile lesions. We also need to understand at the population or health system level what the impact is on resources, cost, and access.”

Ultimately, the living guideline underscores the trade-off between desirable and undesirable effects and the limitations of current evidence to support a recommendation, but CADe has to improve as an iterative AI application with further validation and better training.

With the anticipated improvement in software accuracy as AI machine learning reads increasing numbers of images, Sultan added, “the next version of the software may perform better, especially for polyps that are more clinically significant or for flat sessile serrated polyps, which are harder to detect. We plan to revisit the question in the next year or two and potentially revise the guideline.”

These guidelines were fully funded by the AGA Institute with no funding from any outside agency or industry.

Sultan is supported by the US Food and Drug Administration. Co-authors Shazia Mehmood Siddique, Dennis L. Shung, and Benjamin Lebwohl are supported by grants from the National Institute of Diabetes and Digestive and Kidney Diseases. Theodore R. Levin is supported by the Permanente Medical Group Delivery Science and Applied Research Program. Cesare Hassan is a consultant for Fujifilm and Olympus. Peter S. Liang reported doing research work for Freenome and advisory board work for Guardant Health and Natera.

Kim is the AGA president-elect. He disclosed no competing interests relevant to his comments.

A version of this article appeared on Medscape.com.

An AGA multidisciplinary panel has reached the conclusion that no recommendation can be made for or against the use of computer-aided detection (CADe)–assisted colonoscopy for colorectal cancer (CRC), the third most common cause of cancer mortality in the United States.

The systematic data review is a collaboration between AGA and The BMJ’s MAGIC Rapid Recommendations. The BMJ issued a separate recommendation against CADe shortly after the AGA guideline was published.

Led by Shahnaz S. Sultan, MD, MHSc, AGAF, of the Division of Gastroenterology, Hepatology, and Nutrition at University of Minnesota, Minneapolis, and recently published in Gastroenterology, found only very low certainty of GRADE-based evidence for several critical long-term outcomes, both desirable and undesirable. These included the following: 11 fewer CRCs per 10,000 individuals and two fewer CRC deaths per 10,000 individuals, an increased burden of more intensive surveillance colonoscopies (635 more per 10,000 individuals), and cost and resource implications.

This technology did, however, yield an 8% (95% CI, 6-10) absolute increase in the adenoma detection rate (ADR) and a 2% (95% CI, 0-4) increase in the detection rate of advanced adenomas and/or sessile serrated lesions. “How this translates into a reduction in CRC incidence or death is where we were uncertain,” Sultan said. “Our best effort at trying to translate the ADR and other endoscopy outcomes to CRC incidence and CRC death relied on the modeling study, which included a lot of assumptions, which also contributed to our overall lower certainty.”

The systematic and meta-analysis included 41 randomized controlled trials with more than 32,108 participants who underwent CADe-assisted colonoscopy. This technology was associated with a higher polyp detection rate than standard colonoscopy: 56.1% vs 47.9% (relative risk [RR], 1.22, 95% CI, 1.15-1.28). It also had a higher ADR: 44.8% vs 37.4% (RR, 1.22; 95% CI, 1.16-1.29).

But although CADe-assisted colonoscopy may increase ADR, it carries a risk for overdiagnosis, as most polyps detected during colonoscopy are diminutive (< 5 mm) and of low malignant potential, the panel noted. Approximately 25% of lesions are missed at colonoscopy. More than 15 million colonoscopies are performed annually in the United States, but studies have demonstrated variable quality of colonoscopies across key quality indicators.

“Artificial intelligence [AI] is revolutionizing medicine and healthcare in the field of GI [gastroenterology], and CADe in colonoscopy has been brought to commercialization,” Sultan told GI & Hepatology News. “Unlike many areas of endoscopic research where we often have a finite number of clinical trial data, CADe-assisted colonoscopy intervention has been studied in over 44 randomized controlled trials and numerous nonrandomized, real-world studies. The question of whether or not to adopt this intervention at a health system or practice level is an important question that was prioritized to be addressed as guidance was needed.”

Commenting on the guideline but not involved in its formulation, Larry S. Kim, MD, MBA, AGAF, a gastroenterologist at South Denver Gastroenterology in Denver, Colorado, said his practice group has used the GI Genius AI system in its affiliated hospitals but has so far chosen not to implement the technology at its endoscopy centers. “At the hospital, our physicians have the ability to utilize the system for select patients or not at all,” he told GI & Hepatology News.

The fact that The BMJ reached a different conclusion based on the same data, evidence-grading system, and microsimulation, Kim added, “highlights the point that when evidence for benefit is uncertain, underlying values are critical.” In declining to make a recommendation, the AGA panel balanced the benefit of improved detection of potentially precancerous adenomas vs increased resource utilization in the face of unclear benefit. “With different priorities, other bodies could reasonably decide to recommend either for or against CADe.”

 

The Future

According to Sultan, gastroenterologists need a better understanding of patient values and preferences and the value placed on increased adenoma detection, which may also lead to more lifetime colonoscopies without reducing the risk for CRC. “We need better intermediate- and long-term data on the impact of adenoma detection on interval cancers and CRC incidence,” she said. “We need data on detection of polyps that are more clinically significant such as those 6-10 mm in size, as well as serrated sessile lesions. We also need to understand at the population or health system level what the impact is on resources, cost, and access.”

Ultimately, the living guideline underscores the trade-off between desirable and undesirable effects and the limitations of current evidence to support a recommendation, but CADe has to improve as an iterative AI application with further validation and better training.

With the anticipated improvement in software accuracy as AI machine learning reads increasing numbers of images, Sultan added, “the next version of the software may perform better, especially for polyps that are more clinically significant or for flat sessile serrated polyps, which are harder to detect. We plan to revisit the question in the next year or two and potentially revise the guideline.”

These guidelines were fully funded by the AGA Institute with no funding from any outside agency or industry.

Sultan is supported by the US Food and Drug Administration. Co-authors Shazia Mehmood Siddique, Dennis L. Shung, and Benjamin Lebwohl are supported by grants from the National Institute of Diabetes and Digestive and Kidney Diseases. Theodore R. Levin is supported by the Permanente Medical Group Delivery Science and Applied Research Program. Cesare Hassan is a consultant for Fujifilm and Olympus. Peter S. Liang reported doing research work for Freenome and advisory board work for Guardant Health and Natera.

Kim is the AGA president-elect. He disclosed no competing interests relevant to his comments.

A version of this article appeared on Medscape.com.

An AGA multidisciplinary panel has reached the conclusion that no recommendation can be made for or against the use of computer-aided detection (CADe)–assisted colonoscopy for colorectal cancer (CRC), the third most common cause of cancer mortality in the United States.

The systematic data review is a collaboration between AGA and The BMJ’s MAGIC Rapid Recommendations. The BMJ issued a separate recommendation against CADe shortly after the AGA guideline was published.

Led by Shahnaz S. Sultan, MD, MHSc, AGAF, of the Division of Gastroenterology, Hepatology, and Nutrition at University of Minnesota, Minneapolis, and recently published in Gastroenterology, found only very low certainty of GRADE-based evidence for several critical long-term outcomes, both desirable and undesirable. These included the following: 11 fewer CRCs per 10,000 individuals and two fewer CRC deaths per 10,000 individuals, an increased burden of more intensive surveillance colonoscopies (635 more per 10,000 individuals), and cost and resource implications.

This technology did, however, yield an 8% (95% CI, 6-10) absolute increase in the adenoma detection rate (ADR) and a 2% (95% CI, 0-4) increase in the detection rate of advanced adenomas and/or sessile serrated lesions. “How this translates into a reduction in CRC incidence or death is where we were uncertain,” Sultan said. “Our best effort at trying to translate the ADR and other endoscopy outcomes to CRC incidence and CRC death relied on the modeling study, which included a lot of assumptions, which also contributed to our overall lower certainty.”

The systematic and meta-analysis included 41 randomized controlled trials with more than 32,108 participants who underwent CADe-assisted colonoscopy. This technology was associated with a higher polyp detection rate than standard colonoscopy: 56.1% vs 47.9% (relative risk [RR], 1.22, 95% CI, 1.15-1.28). It also had a higher ADR: 44.8% vs 37.4% (RR, 1.22; 95% CI, 1.16-1.29).

But although CADe-assisted colonoscopy may increase ADR, it carries a risk for overdiagnosis, as most polyps detected during colonoscopy are diminutive (< 5 mm) and of low malignant potential, the panel noted. Approximately 25% of lesions are missed at colonoscopy. More than 15 million colonoscopies are performed annually in the United States, but studies have demonstrated variable quality of colonoscopies across key quality indicators.

“Artificial intelligence [AI] is revolutionizing medicine and healthcare in the field of GI [gastroenterology], and CADe in colonoscopy has been brought to commercialization,” Sultan told GI & Hepatology News. “Unlike many areas of endoscopic research where we often have a finite number of clinical trial data, CADe-assisted colonoscopy intervention has been studied in over 44 randomized controlled trials and numerous nonrandomized, real-world studies. The question of whether or not to adopt this intervention at a health system or practice level is an important question that was prioritized to be addressed as guidance was needed.”

Commenting on the guideline but not involved in its formulation, Larry S. Kim, MD, MBA, AGAF, a gastroenterologist at South Denver Gastroenterology in Denver, Colorado, said his practice group has used the GI Genius AI system in its affiliated hospitals but has so far chosen not to implement the technology at its endoscopy centers. “At the hospital, our physicians have the ability to utilize the system for select patients or not at all,” he told GI & Hepatology News.

The fact that The BMJ reached a different conclusion based on the same data, evidence-grading system, and microsimulation, Kim added, “highlights the point that when evidence for benefit is uncertain, underlying values are critical.” In declining to make a recommendation, the AGA panel balanced the benefit of improved detection of potentially precancerous adenomas vs increased resource utilization in the face of unclear benefit. “With different priorities, other bodies could reasonably decide to recommend either for or against CADe.”

 

The Future

According to Sultan, gastroenterologists need a better understanding of patient values and preferences and the value placed on increased adenoma detection, which may also lead to more lifetime colonoscopies without reducing the risk for CRC. “We need better intermediate- and long-term data on the impact of adenoma detection on interval cancers and CRC incidence,” she said. “We need data on detection of polyps that are more clinically significant such as those 6-10 mm in size, as well as serrated sessile lesions. We also need to understand at the population or health system level what the impact is on resources, cost, and access.”

Ultimately, the living guideline underscores the trade-off between desirable and undesirable effects and the limitations of current evidence to support a recommendation, but CADe has to improve as an iterative AI application with further validation and better training.

With the anticipated improvement in software accuracy as AI machine learning reads increasing numbers of images, Sultan added, “the next version of the software may perform better, especially for polyps that are more clinically significant or for flat sessile serrated polyps, which are harder to detect. We plan to revisit the question in the next year or two and potentially revise the guideline.”

These guidelines were fully funded by the AGA Institute with no funding from any outside agency or industry.

Sultan is supported by the US Food and Drug Administration. Co-authors Shazia Mehmood Siddique, Dennis L. Shung, and Benjamin Lebwohl are supported by grants from the National Institute of Diabetes and Digestive and Kidney Diseases. Theodore R. Levin is supported by the Permanente Medical Group Delivery Science and Applied Research Program. Cesare Hassan is a consultant for Fujifilm and Olympus. Peter S. Liang reported doing research work for Freenome and advisory board work for Guardant Health and Natera.

Kim is the AGA president-elect. He disclosed no competing interests relevant to his comments.

A version of this article appeared on Medscape.com.

Short-term adherence to a palatable elemental diet (PED) significantly improved symptoms and the gut microbiota in adults with microbiome-driven gastrointestinal disorders, according to a new study.

“Elemental diets have long shown promise for treating gastrointestinal disorders like Crohn’s disease, eosinophilic esophagitis, SIBO (small intestinal bacterial overgrowth), and IMO (intestinal methanogen overgrowth), but poor palatability has limited their use,” lead author Ali Rezaie, MD, medical director of the Gastrointestinal (GI) Motility Program and director of Bioinformatics at Cedars-Sinai Medical Center, Los Angeles, told GI & Hepatology News.

Elemental diets are specialized formulas tailored to meet an individual’s specific nutritional needs and daily requirements for vitamins, minerals, fat, free amino acids, and carbohydrates.

In SIBO and IMO specifically, only about half the patients respond to antibiotics, and many require repeat treatments, which underscores the need for effective nonantibiotic alternatives, said Rezaie. “This is the first prospective trial using a PED, aiming to make this approach both viable and accessible for patients,” he noted.

 

Assessing a Novel Diet in IMO and SIBO

In the study, which was recently published in Clinical Gastroenterology and Hepatology, Rezaie and colleagues enrolled 30 adults with IMO (40%), SIBO (20%), or both (40%). The mean participant age was 45 years, and 63% were women.

All participants completed 2 weeks of a PED, transitioned to 2-3 days of a bland diet, and then resumed their regular diets for 2 weeks.

The diet consisted of multiple 300-calorie packets, adjusted for individual caloric needs. Participants could consume additional packets for hunger but were prohibited from eating other foods. There was no restriction on water intake.

The primary endpoint was changes in stool microbiome after the PED and reintroduction of regular food. Secondary endpoints included lactose breath test normalization to determine bacterial overgrowth in the gut, symptom response, and adverse events.

Researchers collected 29 stool samples at baseline, 27 post-PED, and 27 at study conclusion (2 weeks post-diet).

 

Key Outcomes

Although the stool samples’ alpha diversity decreased after the PED, the difference was not statistically significant at the end of the study. However, 30 bacterial families showed significant differences in relative abundance post-PED.

Daily symptom severity improved significantly during the second week of the diet compared with baseline, with reduction in abdominal discomfort, bloating, distention, constipation, and flatulence. Further significant improvements in measures such as abdominal pain, diarrhea, fatigue, urgency, and brain fog were observed after reintroducing regular food.

“We observed 73% breath test normalization and 83% global symptom relief — with 100% adherence and tolerance to 2 weeks of exclusive PED,” Rezaie told GI & Hepatology News. No serious adverse events occurred during the study, he added.

Lactose breath test normalization rates post-PED were 58% in patients with IMO, 100% in patients with SIBO, and 75% in those with both conditions.

The extent of patient response to PED was notable, given that 83% had failed prior treatments, Rezaie said.

“While we expected benefit based on palatability improvements and prior retrospective data, the rapid reduction in methane and hydrogen gas — and the sustained microbiome modulation even after reintroducing a regular diet — exceeded expectations,” he said. A significant reduction in visceral fat was another novel finding.

“This study reinforces the power of diet as a therapeutic tool,” Rezaie said, adding that the results show that elemental diets can be palatable, thereby improving patient adherence, tolerance, and, eventually, effectiveness. This is particularly valuable for patients with SIBO and IMO who do not tolerate or respond to antibiotics, prefer nonpharmacologic options, or experience recurrent symptoms after antibiotic treatment.

 

Limitations and Next Steps

Study limitations included the lack of a placebo group with a sham diet, the short follow-up after reintroducing a regular diet, and the inability to assess microbial gene function.

However, the results support the safety, tolerance, and benefit of a PED in patients with IMO/SIBO. Personalized dietary interventions that support the growth of beneficial bacteria may be an effective approach to treating these disorders, Rezaie and colleagues noted in their publication.

Although the current study is a promising first step, longer-term studies are needed to evaluate the durability of microbiome and symptom improvements, Rezaie said.

 

Making the Most of Microbiome Manipulation

Elemental diets may help modulate the gut microbiome while reducing immune activation, making them attractive for microbiome-targeted gastrointestinal therapies, Jatin Roper, MD, a gastroenterologist at Duke University, Durham, North Carolina, told GI & Hepatology News.

“Antibiotics are only effective in half of SIBO cases and often require retreatment, so better therapies are needed,” said Roper, who was not affiliated with the study. He added that its findings confirmed the researchers’ hypothesis that a PED can be both safe and effective in patients with SIBO.

Roper noted the 83% symptom improvement as the study’s most unexpected and encouraging finding, as it represents a substantial improvement compared with standard antibiotic therapy. “It is also surprising that the tolerance rate of the elemental diet in this study was 100%,” he said.

However, diet palatability remains a major barrier in real-world practice.

“Adherence rates are likely to be far lower than in trials in which patients are closely monitored, and this challenge will not be easily overcome,” he added.

The study’s limitations, including the lack of metagenomic analysis and a placebo group, are important to address in future research, Roper said. In particular, controlled trials of elemental diets are needed to determine whether microbiome changes are directly responsible for symptom improvement.

The study was supported in part by Good LFE and the John and Geraldine Cusenza Foundation. Rezaie disclosed serving as a consultant/speaker for Bausch Health and having equity in Dieta Health, Gemelli Biotech, and Good LFE. Roper had no financial conflicts to disclose.

A version of this article first appeared on Medscape.com.

Short-term adherence to a palatable elemental diet (PED) significantly improved symptoms and the gut microbiota in adults with microbiome-driven gastrointestinal disorders, according to a new study.

“Elemental diets have long shown promise for treating gastrointestinal disorders like Crohn’s disease, eosinophilic esophagitis, SIBO (small intestinal bacterial overgrowth), and IMO (intestinal methanogen overgrowth), but poor palatability has limited their use,” lead author Ali Rezaie, MD, medical director of the Gastrointestinal (GI) Motility Program and director of Bioinformatics at Cedars-Sinai Medical Center, Los Angeles, told GI & Hepatology News.

Elemental diets are specialized formulas tailored to meet an individual’s specific nutritional needs and daily requirements for vitamins, minerals, fat, free amino acids, and carbohydrates.

In SIBO and IMO specifically, only about half the patients respond to antibiotics, and many require repeat treatments, which underscores the need for effective nonantibiotic alternatives, said Rezaie. “This is the first prospective trial using a PED, aiming to make this approach both viable and accessible for patients,” he noted.

 

Assessing a Novel Diet in IMO and SIBO

In the study, which was recently published in Clinical Gastroenterology and Hepatology, Rezaie and colleagues enrolled 30 adults with IMO (40%), SIBO (20%), or both (40%). The mean participant age was 45 years, and 63% were women.

All participants completed 2 weeks of a PED, transitioned to 2-3 days of a bland diet, and then resumed their regular diets for 2 weeks.

The diet consisted of multiple 300-calorie packets, adjusted for individual caloric needs. Participants could consume additional packets for hunger but were prohibited from eating other foods. There was no restriction on water intake.

The primary endpoint was changes in stool microbiome after the PED and reintroduction of regular food. Secondary endpoints included lactose breath test normalization to determine bacterial overgrowth in the gut, symptom response, and adverse events.

Researchers collected 29 stool samples at baseline, 27 post-PED, and 27 at study conclusion (2 weeks post-diet).

 

Key Outcomes

Although the stool samples’ alpha diversity decreased after the PED, the difference was not statistically significant at the end of the study. However, 30 bacterial families showed significant differences in relative abundance post-PED.

Daily symptom severity improved significantly during the second week of the diet compared with baseline, with reduction in abdominal discomfort, bloating, distention, constipation, and flatulence. Further significant improvements in measures such as abdominal pain, diarrhea, fatigue, urgency, and brain fog were observed after reintroducing regular food.

“We observed 73% breath test normalization and 83% global symptom relief — with 100% adherence and tolerance to 2 weeks of exclusive PED,” Rezaie told GI & Hepatology News. No serious adverse events occurred during the study, he added.

Lactose breath test normalization rates post-PED were 58% in patients with IMO, 100% in patients with SIBO, and 75% in those with both conditions.

The extent of patient response to PED was notable, given that 83% had failed prior treatments, Rezaie said.

“While we expected benefit based on palatability improvements and prior retrospective data, the rapid reduction in methane and hydrogen gas — and the sustained microbiome modulation even after reintroducing a regular diet — exceeded expectations,” he said. A significant reduction in visceral fat was another novel finding.

“This study reinforces the power of diet as a therapeutic tool,” Rezaie said, adding that the results show that elemental diets can be palatable, thereby improving patient adherence, tolerance, and, eventually, effectiveness. This is particularly valuable for patients with SIBO and IMO who do not tolerate or respond to antibiotics, prefer nonpharmacologic options, or experience recurrent symptoms after antibiotic treatment.

 

Limitations and Next Steps

Study limitations included the lack of a placebo group with a sham diet, the short follow-up after reintroducing a regular diet, and the inability to assess microbial gene function.

However, the results support the safety, tolerance, and benefit of a PED in patients with IMO/SIBO. Personalized dietary interventions that support the growth of beneficial bacteria may be an effective approach to treating these disorders, Rezaie and colleagues noted in their publication.

Although the current study is a promising first step, longer-term studies are needed to evaluate the durability of microbiome and symptom improvements, Rezaie said.

 

Making the Most of Microbiome Manipulation

Elemental diets may help modulate the gut microbiome while reducing immune activation, making them attractive for microbiome-targeted gastrointestinal therapies, Jatin Roper, MD, a gastroenterologist at Duke University, Durham, North Carolina, told GI & Hepatology News.

“Antibiotics are only effective in half of SIBO cases and often require retreatment, so better therapies are needed,” said Roper, who was not affiliated with the study. He added that its findings confirmed the researchers’ hypothesis that a PED can be both safe and effective in patients with SIBO.

Roper noted the 83% symptom improvement as the study’s most unexpected and encouraging finding, as it represents a substantial improvement compared with standard antibiotic therapy. “It is also surprising that the tolerance rate of the elemental diet in this study was 100%,” he said.

However, diet palatability remains a major barrier in real-world practice.

“Adherence rates are likely to be far lower than in trials in which patients are closely monitored, and this challenge will not be easily overcome,” he added.

The study’s limitations, including the lack of metagenomic analysis and a placebo group, are important to address in future research, Roper said. In particular, controlled trials of elemental diets are needed to determine whether microbiome changes are directly responsible for symptom improvement.

The study was supported in part by Good LFE and the John and Geraldine Cusenza Foundation. Rezaie disclosed serving as a consultant/speaker for Bausch Health and having equity in Dieta Health, Gemelli Biotech, and Good LFE. Roper had no financial conflicts to disclose.

A version of this article first appeared on Medscape.com.

Short-term adherence to a palatable elemental diet (PED) significantly improved symptoms and the gut microbiota in adults with microbiome-driven gastrointestinal disorders, according to a new study.

“Elemental diets have long shown promise for treating gastrointestinal disorders like Crohn’s disease, eosinophilic esophagitis, SIBO (small intestinal bacterial overgrowth), and IMO (intestinal methanogen overgrowth), but poor palatability has limited their use,” lead author Ali Rezaie, MD, medical director of the Gastrointestinal (GI) Motility Program and director of Bioinformatics at Cedars-Sinai Medical Center, Los Angeles, told GI & Hepatology News.

Elemental diets are specialized formulas tailored to meet an individual’s specific nutritional needs and daily requirements for vitamins, minerals, fat, free amino acids, and carbohydrates.

In SIBO and IMO specifically, only about half the patients respond to antibiotics, and many require repeat treatments, which underscores the need for effective nonantibiotic alternatives, said Rezaie. “This is the first prospective trial using a PED, aiming to make this approach both viable and accessible for patients,” he noted.

 

Assessing a Novel Diet in IMO and SIBO

In the study, which was recently published in Clinical Gastroenterology and Hepatology, Rezaie and colleagues enrolled 30 adults with IMO (40%), SIBO (20%), or both (40%). The mean participant age was 45 years, and 63% were women.

All participants completed 2 weeks of a PED, transitioned to 2-3 days of a bland diet, and then resumed their regular diets for 2 weeks.

The diet consisted of multiple 300-calorie packets, adjusted for individual caloric needs. Participants could consume additional packets for hunger but were prohibited from eating other foods. There was no restriction on water intake.

The primary endpoint was changes in stool microbiome after the PED and reintroduction of regular food. Secondary endpoints included lactose breath test normalization to determine bacterial overgrowth in the gut, symptom response, and adverse events.

Researchers collected 29 stool samples at baseline, 27 post-PED, and 27 at study conclusion (2 weeks post-diet).

 

Key Outcomes

Although the stool samples’ alpha diversity decreased after the PED, the difference was not statistically significant at the end of the study. However, 30 bacterial families showed significant differences in relative abundance post-PED.

Daily symptom severity improved significantly during the second week of the diet compared with baseline, with reduction in abdominal discomfort, bloating, distention, constipation, and flatulence. Further significant improvements in measures such as abdominal pain, diarrhea, fatigue, urgency, and brain fog were observed after reintroducing regular food.

“We observed 73% breath test normalization and 83% global symptom relief — with 100% adherence and tolerance to 2 weeks of exclusive PED,” Rezaie told GI & Hepatology News. No serious adverse events occurred during the study, he added.

Lactose breath test normalization rates post-PED were 58% in patients with IMO, 100% in patients with SIBO, and 75% in those with both conditions.

The extent of patient response to PED was notable, given that 83% had failed prior treatments, Rezaie said.

“While we expected benefit based on palatability improvements and prior retrospective data, the rapid reduction in methane and hydrogen gas — and the sustained microbiome modulation even after reintroducing a regular diet — exceeded expectations,” he said. A significant reduction in visceral fat was another novel finding.

“This study reinforces the power of diet as a therapeutic tool,” Rezaie said, adding that the results show that elemental diets can be palatable, thereby improving patient adherence, tolerance, and, eventually, effectiveness. This is particularly valuable for patients with SIBO and IMO who do not tolerate or respond to antibiotics, prefer nonpharmacologic options, or experience recurrent symptoms after antibiotic treatment.

 

Limitations and Next Steps

Study limitations included the lack of a placebo group with a sham diet, the short follow-up after reintroducing a regular diet, and the inability to assess microbial gene function.

However, the results support the safety, tolerance, and benefit of a PED in patients with IMO/SIBO. Personalized dietary interventions that support the growth of beneficial bacteria may be an effective approach to treating these disorders, Rezaie and colleagues noted in their publication.

Although the current study is a promising first step, longer-term studies are needed to evaluate the durability of microbiome and symptom improvements, Rezaie said.

 

Making the Most of Microbiome Manipulation

Elemental diets may help modulate the gut microbiome while reducing immune activation, making them attractive for microbiome-targeted gastrointestinal therapies, Jatin Roper, MD, a gastroenterologist at Duke University, Durham, North Carolina, told GI & Hepatology News.

“Antibiotics are only effective in half of SIBO cases and often require retreatment, so better therapies are needed,” said Roper, who was not affiliated with the study. He added that its findings confirmed the researchers’ hypothesis that a PED can be both safe and effective in patients with SIBO.

Roper noted the 83% symptom improvement as the study’s most unexpected and encouraging finding, as it represents a substantial improvement compared with standard antibiotic therapy. “It is also surprising that the tolerance rate of the elemental diet in this study was 100%,” he said.

However, diet palatability remains a major barrier in real-world practice.

“Adherence rates are likely to be far lower than in trials in which patients are closely monitored, and this challenge will not be easily overcome,” he added.

The study’s limitations, including the lack of metagenomic analysis and a placebo group, are important to address in future research, Roper said. In particular, controlled trials of elemental diets are needed to determine whether microbiome changes are directly responsible for symptom improvement.

The study was supported in part by Good LFE and the John and Geraldine Cusenza Foundation. Rezaie disclosed serving as a consultant/speaker for Bausch Health and having equity in Dieta Health, Gemelli Biotech, and Good LFE. Roper had no financial conflicts to disclose.

A version of this article first appeared on Medscape.com.

Wearable devices like the Apple Watch and Fitbit may help identify and predict inflammatory bowel disease (IBD) flares, and even distinguish between inflammatory and purely symptomatic episodes, according to investigators.

These findings suggest that widely used consumer wearables could support long-term monitoring of IBD and other chronic inflammatory conditions, lead author Robert P. Hirten, MD, of Icahn School of Medicine at Mount Sinai, New York, and colleagues reported.

 

“Wearable devices are an increasingly accepted tool for monitoring health and disease,” the investigators wrote in Gastroenterology. “They are frequently used in non–inflammatory-based diseases for remote patient monitoring, allowing individuals to be monitored outside of the clinical setting, which has resulted in improved outcomes in multiple disease states.”

Progress has been slower for inflammatory conditions, the investigators noted, despite interest from both providers and patients. Prior studies have explored activity and sleep tracking, or sweat-based biomarkers, as potential tools for monitoring IBD. 

Hirten and colleagues took a novel approach, focusing on physiologic changes driven by autonomic nervous system dysfunction — a hallmark of chronic inflammation. Conditions like IBD are associated with reduced parasympathetic activity and increased sympathetic tone, which in turn affect heart rate and heart rate variability. Heart rate tends to rise during flares, while heart rate variability decreases.

Their prospective cohort study included 309 adults with Crohn’s disease (n = 196) or ulcerative colitis (n = 113). Participants used their own or a study-provided Apple Watch, Fitbit, or Oura Ring to passively collect physiological data, including heart rate, resting heart rate, heart rate variability, and step count. A subset of Apple Watch users also contributed oxygen saturation data.

Participants also completed daily symptom surveys using a custom smartphone app and reported laboratory values such as C-reactive protein, erythrocyte sedimentation rate, and fecal calprotectin, as part of routine care. These data were used to identify symptomatic and inflammatory flare periods.

Over a mean follow-up of about 7 months, the physiological data consistently distinguished both types of flares from periods of remission. Heart rate variability dropped significantly during flares, while heart rate and resting heart rate increased. Step counts decreased during inflammatory flares but not during symptom-only flares. Oxygen saturation stayed mostly the same, except for a slight drop seen in participants with Crohn’s disease.

These physiological changes could be detected as early as 7 weeks before a flare. Predictive models that combined multiple metrics — heart rate variability, heart rate, resting heart rate, and step count — were highly accurate, with F1 scores as high as 0.90 for predicting inflammatory flares and 0.83 for predicting symptomatic flares.

In addition, wearable data helped differentiate between flares caused by active inflammation and those driven by symptoms alone. Even when symptoms were similar, heart rate variability, heart rate, and resting heart rate were significantly higher when inflammation was present—suggesting wearable devices may help address the common mismatch between symptoms and actual disease activity in IBD.

“These findings support the further evaluation of wearable devices in the monitoring of IBD,” the investigators concluded.

The study was supported by the National Institute of Diabetes and Digestive and Kidney Diseases and Ms. Jenny Steingart. The investigators disclosed additional relationships with Agomab, Lilly, Merck, and others.

 

Wearable devices like the Apple Watch and Fitbit may help identify and predict inflammatory bowel disease (IBD) flares, and even distinguish between inflammatory and purely symptomatic episodes, according to investigators.

These findings suggest that widely used consumer wearables could support long-term monitoring of IBD and other chronic inflammatory conditions, lead author Robert P. Hirten, MD, of Icahn School of Medicine at Mount Sinai, New York, and colleagues reported.

 

“Wearable devices are an increasingly accepted tool for monitoring health and disease,” the investigators wrote in Gastroenterology. “They are frequently used in non–inflammatory-based diseases for remote patient monitoring, allowing individuals to be monitored outside of the clinical setting, which has resulted in improved outcomes in multiple disease states.”

Progress has been slower for inflammatory conditions, the investigators noted, despite interest from both providers and patients. Prior studies have explored activity and sleep tracking, or sweat-based biomarkers, as potential tools for monitoring IBD. 

Hirten and colleagues took a novel approach, focusing on physiologic changes driven by autonomic nervous system dysfunction — a hallmark of chronic inflammation. Conditions like IBD are associated with reduced parasympathetic activity and increased sympathetic tone, which in turn affect heart rate and heart rate variability. Heart rate tends to rise during flares, while heart rate variability decreases.

Their prospective cohort study included 309 adults with Crohn’s disease (n = 196) or ulcerative colitis (n = 113). Participants used their own or a study-provided Apple Watch, Fitbit, or Oura Ring to passively collect physiological data, including heart rate, resting heart rate, heart rate variability, and step count. A subset of Apple Watch users also contributed oxygen saturation data.

Participants also completed daily symptom surveys using a custom smartphone app and reported laboratory values such as C-reactive protein, erythrocyte sedimentation rate, and fecal calprotectin, as part of routine care. These data were used to identify symptomatic and inflammatory flare periods.

Over a mean follow-up of about 7 months, the physiological data consistently distinguished both types of flares from periods of remission. Heart rate variability dropped significantly during flares, while heart rate and resting heart rate increased. Step counts decreased during inflammatory flares but not during symptom-only flares. Oxygen saturation stayed mostly the same, except for a slight drop seen in participants with Crohn’s disease.

These physiological changes could be detected as early as 7 weeks before a flare. Predictive models that combined multiple metrics — heart rate variability, heart rate, resting heart rate, and step count — were highly accurate, with F1 scores as high as 0.90 for predicting inflammatory flares and 0.83 for predicting symptomatic flares.

In addition, wearable data helped differentiate between flares caused by active inflammation and those driven by symptoms alone. Even when symptoms were similar, heart rate variability, heart rate, and resting heart rate were significantly higher when inflammation was present—suggesting wearable devices may help address the common mismatch between symptoms and actual disease activity in IBD.

“These findings support the further evaluation of wearable devices in the monitoring of IBD,” the investigators concluded.

The study was supported by the National Institute of Diabetes and Digestive and Kidney Diseases and Ms. Jenny Steingart. The investigators disclosed additional relationships with Agomab, Lilly, Merck, and others.

 

Wearable devices like the Apple Watch and Fitbit may help identify and predict inflammatory bowel disease (IBD) flares, and even distinguish between inflammatory and purely symptomatic episodes, according to investigators.

These findings suggest that widely used consumer wearables could support long-term monitoring of IBD and other chronic inflammatory conditions, lead author Robert P. Hirten, MD, of Icahn School of Medicine at Mount Sinai, New York, and colleagues reported.

 

“Wearable devices are an increasingly accepted tool for monitoring health and disease,” the investigators wrote in Gastroenterology. “They are frequently used in non–inflammatory-based diseases for remote patient monitoring, allowing individuals to be monitored outside of the clinical setting, which has resulted in improved outcomes in multiple disease states.”

Progress has been slower for inflammatory conditions, the investigators noted, despite interest from both providers and patients. Prior studies have explored activity and sleep tracking, or sweat-based biomarkers, as potential tools for monitoring IBD. 

Hirten and colleagues took a novel approach, focusing on physiologic changes driven by autonomic nervous system dysfunction — a hallmark of chronic inflammation. Conditions like IBD are associated with reduced parasympathetic activity and increased sympathetic tone, which in turn affect heart rate and heart rate variability. Heart rate tends to rise during flares, while heart rate variability decreases.

Their prospective cohort study included 309 adults with Crohn’s disease (n = 196) or ulcerative colitis (n = 113). Participants used their own or a study-provided Apple Watch, Fitbit, or Oura Ring to passively collect physiological data, including heart rate, resting heart rate, heart rate variability, and step count. A subset of Apple Watch users also contributed oxygen saturation data.

Participants also completed daily symptom surveys using a custom smartphone app and reported laboratory values such as C-reactive protein, erythrocyte sedimentation rate, and fecal calprotectin, as part of routine care. These data were used to identify symptomatic and inflammatory flare periods.

Over a mean follow-up of about 7 months, the physiological data consistently distinguished both types of flares from periods of remission. Heart rate variability dropped significantly during flares, while heart rate and resting heart rate increased. Step counts decreased during inflammatory flares but not during symptom-only flares. Oxygen saturation stayed mostly the same, except for a slight drop seen in participants with Crohn’s disease.

These physiological changes could be detected as early as 7 weeks before a flare. Predictive models that combined multiple metrics — heart rate variability, heart rate, resting heart rate, and step count — were highly accurate, with F1 scores as high as 0.90 for predicting inflammatory flares and 0.83 for predicting symptomatic flares.

In addition, wearable data helped differentiate between flares caused by active inflammation and those driven by symptoms alone. Even when symptoms were similar, heart rate variability, heart rate, and resting heart rate were significantly higher when inflammation was present—suggesting wearable devices may help address the common mismatch between symptoms and actual disease activity in IBD.

“These findings support the further evaluation of wearable devices in the monitoring of IBD,” the investigators concluded.

The study was supported by the National Institute of Diabetes and Digestive and Kidney Diseases and Ms. Jenny Steingart. The investigators disclosed additional relationships with Agomab, Lilly, Merck, and others.

 

US counties with limited access to healthy food (food deserts) or a high density of unhealthy food outlets (food swamps) have higher mortality rates from metabolic dysfunction–associated steatotic liver disease (MASLD), according to investigators.

These findings highlight the importance of addressing disparities in food environments and social determinants of health to help reduce MASLD-related mortality, lead author Annette Paik, MD, of Inova Health System, Falls Church, Virginia, and colleagues reported.

“Recent studies indicate that food swamps and deserts, as surrogates for food insecurity, are linked to poor glycemic control and higher adult obesity rates,” the investigators wrote in Clinical Gastroenterology and Hepatology. “Understanding the intersection of these factors with sociodemographic and clinical variables offers insights into MASLD-related outcomes, including mortality.”

To this end, the present study examined the association between food environments and MASLD-related mortality across more than 2,195 US counties. County-level mortality data were obtained from the CDC WONDER database (2016-2020) and linked to food environment data from the US Department of Agriculture Food Environment Atlas using Federal Information Processing Standards (FIPS) codes. Food deserts were defined as low-income areas with limited access to grocery stores, while food swamps were characterized by a predominance of unhealthy food outlets relative to healthy ones.

Additional data on obesity, type 2 diabetes (T2D), and nine social determinants of health were obtained from CDC PLACES and other publicly available datasets. Counties were stratified into quartiles based on MASLD-related mortality rates. Population-weighted mixed-effects linear regression models were used to evaluate associations between food environment exposures and MASLD mortality, adjusting for region, rural-urban status, age, sex, race, insurance coverage, chronic dis-ease prevalence, SNAP participation, and access to exercise facilities.

Counties with the worst food environments had significantly higher MASLD-related mortality, even after adjusting for clinical and sociodemographic factors. Compared with counties in the lowest quartile of MASLD mortality, those in the highest quartile had a greater proportion of food deserts (22.3% vs 14.9%; P < .001) and food swamps (73.1% vs 65.7%; P < .001). They also had a significantly higher prevalence of obesity (40.5% vs 32.5%), type 2 diabetes (15.8% vs 11.4%), and physical inactivity (33.7% vs 24.9%).

Demographically, counties with higher MASLD mortality had significantly larger proportions of Black and Hispanic residents, and were more likely to be rural and located in the South. These counties also had significantly lower median household incomes, higher poverty rates, fewer adults with a college education, lower access to exercise opportunities, greater SNAP participation, less broadband access, and more uninsured adults.

In multivariable regression models, both food deserts and food swamps remained independently associated with MASLD mortality. Counties in the highest quartile of food desert exposure had a 14.5% higher MASLD mortality rate, compared with the lowest quartile (P = .001), and those in the highest quartile for food swamp exposure had a 13.9% higher mortality rate (P = .005).

Type 2 diabetes, physical inactivity, and lack of health insurance were also independently associated with increased MASLD-related mortality. 

“Implementing public health interventions that address the specific environmental factors of each county can help US policymakers promote access to healthy, culturally appropriate food choices at affordable prices and reduce the consumption of poor-quality food,” the investigators wrote. “Moreover, improving access to parks and exercise facilities can further enhance the impact of healthy nutrition. These strategies could help curb the growing epidemic of metabolic diseases, including MASLD and related mortality.”

This study was supported by King Faisal Specialist Hospital & Research Center, the Global NASH Council, Center for Outcomes Research in Liver Diseases, and the Beatty Liver and Obesity Research Fund, Inova Health System. The investigators disclosed no conflicts of interest.
 

US counties with limited access to healthy food (food deserts) or a high density of unhealthy food outlets (food swamps) have higher mortality rates from metabolic dysfunction–associated steatotic liver disease (MASLD), according to investigators.

These findings highlight the importance of addressing disparities in food environments and social determinants of health to help reduce MASLD-related mortality, lead author Annette Paik, MD, of Inova Health System, Falls Church, Virginia, and colleagues reported.

“Recent studies indicate that food swamps and deserts, as surrogates for food insecurity, are linked to poor glycemic control and higher adult obesity rates,” the investigators wrote in Clinical Gastroenterology and Hepatology. “Understanding the intersection of these factors with sociodemographic and clinical variables offers insights into MASLD-related outcomes, including mortality.”

To this end, the present study examined the association between food environments and MASLD-related mortality across more than 2,195 US counties. County-level mortality data were obtained from the CDC WONDER database (2016-2020) and linked to food environment data from the US Department of Agriculture Food Environment Atlas using Federal Information Processing Standards (FIPS) codes. Food deserts were defined as low-income areas with limited access to grocery stores, while food swamps were characterized by a predominance of unhealthy food outlets relative to healthy ones.

Additional data on obesity, type 2 diabetes (T2D), and nine social determinants of health were obtained from CDC PLACES and other publicly available datasets. Counties were stratified into quartiles based on MASLD-related mortality rates. Population-weighted mixed-effects linear regression models were used to evaluate associations between food environment exposures and MASLD mortality, adjusting for region, rural-urban status, age, sex, race, insurance coverage, chronic dis-ease prevalence, SNAP participation, and access to exercise facilities.

Counties with the worst food environments had significantly higher MASLD-related mortality, even after adjusting for clinical and sociodemographic factors. Compared with counties in the lowest quartile of MASLD mortality, those in the highest quartile had a greater proportion of food deserts (22.3% vs 14.9%; P < .001) and food swamps (73.1% vs 65.7%; P < .001). They also had a significantly higher prevalence of obesity (40.5% vs 32.5%), type 2 diabetes (15.8% vs 11.4%), and physical inactivity (33.7% vs 24.9%).

Demographically, counties with higher MASLD mortality had significantly larger proportions of Black and Hispanic residents, and were more likely to be rural and located in the South. These counties also had significantly lower median household incomes, higher poverty rates, fewer adults with a college education, lower access to exercise opportunities, greater SNAP participation, less broadband access, and more uninsured adults.

In multivariable regression models, both food deserts and food swamps remained independently associated with MASLD mortality. Counties in the highest quartile of food desert exposure had a 14.5% higher MASLD mortality rate, compared with the lowest quartile (P = .001), and those in the highest quartile for food swamp exposure had a 13.9% higher mortality rate (P = .005).

Type 2 diabetes, physical inactivity, and lack of health insurance were also independently associated with increased MASLD-related mortality. 

“Implementing public health interventions that address the specific environmental factors of each county can help US policymakers promote access to healthy, culturally appropriate food choices at affordable prices and reduce the consumption of poor-quality food,” the investigators wrote. “Moreover, improving access to parks and exercise facilities can further enhance the impact of healthy nutrition. These strategies could help curb the growing epidemic of metabolic diseases, including MASLD and related mortality.”

This study was supported by King Faisal Specialist Hospital & Research Center, the Global NASH Council, Center for Outcomes Research in Liver Diseases, and the Beatty Liver and Obesity Research Fund, Inova Health System. The investigators disclosed no conflicts of interest.
 

US counties with limited access to healthy food (food deserts) or a high density of unhealthy food outlets (food swamps) have higher mortality rates from metabolic dysfunction–associated steatotic liver disease (MASLD), according to investigators.

These findings highlight the importance of addressing disparities in food environments and social determinants of health to help reduce MASLD-related mortality, lead author Annette Paik, MD, of Inova Health System, Falls Church, Virginia, and colleagues reported.

“Recent studies indicate that food swamps and deserts, as surrogates for food insecurity, are linked to poor glycemic control and higher adult obesity rates,” the investigators wrote in Clinical Gastroenterology and Hepatology. “Understanding the intersection of these factors with sociodemographic and clinical variables offers insights into MASLD-related outcomes, including mortality.”

To this end, the present study examined the association between food environments and MASLD-related mortality across more than 2,195 US counties. County-level mortality data were obtained from the CDC WONDER database (2016-2020) and linked to food environment data from the US Department of Agriculture Food Environment Atlas using Federal Information Processing Standards (FIPS) codes. Food deserts were defined as low-income areas with limited access to grocery stores, while food swamps were characterized by a predominance of unhealthy food outlets relative to healthy ones.

Additional data on obesity, type 2 diabetes (T2D), and nine social determinants of health were obtained from CDC PLACES and other publicly available datasets. Counties were stratified into quartiles based on MASLD-related mortality rates. Population-weighted mixed-effects linear regression models were used to evaluate associations between food environment exposures and MASLD mortality, adjusting for region, rural-urban status, age, sex, race, insurance coverage, chronic dis-ease prevalence, SNAP participation, and access to exercise facilities.

Counties with the worst food environments had significantly higher MASLD-related mortality, even after adjusting for clinical and sociodemographic factors. Compared with counties in the lowest quartile of MASLD mortality, those in the highest quartile had a greater proportion of food deserts (22.3% vs 14.9%; P < .001) and food swamps (73.1% vs 65.7%; P < .001). They also had a significantly higher prevalence of obesity (40.5% vs 32.5%), type 2 diabetes (15.8% vs 11.4%), and physical inactivity (33.7% vs 24.9%).

Demographically, counties with higher MASLD mortality had significantly larger proportions of Black and Hispanic residents, and were more likely to be rural and located in the South. These counties also had significantly lower median household incomes, higher poverty rates, fewer adults with a college education, lower access to exercise opportunities, greater SNAP participation, less broadband access, and more uninsured adults.

In multivariable regression models, both food deserts and food swamps remained independently associated with MASLD mortality. Counties in the highest quartile of food desert exposure had a 14.5% higher MASLD mortality rate, compared with the lowest quartile (P = .001), and those in the highest quartile for food swamp exposure had a 13.9% higher mortality rate (P = .005).

Type 2 diabetes, physical inactivity, and lack of health insurance were also independently associated with increased MASLD-related mortality. 

“Implementing public health interventions that address the specific environmental factors of each county can help US policymakers promote access to healthy, culturally appropriate food choices at affordable prices and reduce the consumption of poor-quality food,” the investigators wrote. “Moreover, improving access to parks and exercise facilities can further enhance the impact of healthy nutrition. These strategies could help curb the growing epidemic of metabolic diseases, including MASLD and related mortality.”

This study was supported by King Faisal Specialist Hospital & Research Center, the Global NASH Council, Center for Outcomes Research in Liver Diseases, and the Beatty Liver and Obesity Research Fund, Inova Health System. The investigators disclosed no conflicts of interest.
 

Only 1 in 6 US veterans with chronic hepatitis B (CHB) is tested for hepatitis D virus (HDV)—a coinfection associated with significantly higher risks of cirrhosis and hepatic decompensation—according to new findings.

The low testing rate suggests limited awareness of HDV-associated risks in patients with CHB, and underscores the need for earlier testing and diagnosis, lead author Robert J. Wong, MD, of Stanford University School of Medicine, Stanford, California, and colleagues, reported.

“Data among US populations are lacking to describe the epidemiology and long-term outcomes of patients with CHB and concurrent HDV infection,” the investigators wrote in Gastro Hep Advances (2025 Oct. doi: 10.1016/j.gastha.2024.10.015).

Prior studies have found that only 6% to 19% of patients with CHB get tested for HDV, and among those tested, the prevalence is relatively low—between 2% and 4.6%. Although relatively uncommon, HDV carries a substantial clinical and economic burden, Dr. Wong and colleagues noted, highlighting the importance of clinical awareness and accurate epidemiologic data.

The present study analyzed data from the Veterans Affairs (VA) Corporate Data Warehouse between 2010 and 2023. Adults with CHB were identified based on laboratory-confirmed markers and ICD-9/10 codes. HDV testing (anti-HDV antibody and HDV RNA) was assessed, and predictors of testing were evaluated using multivariable logistic regression.

To examine liver-related outcomes, patients who tested positive for HDV were propensity score–matched 1:2 with CHB patients who tested negative. Matching accounted for age, sex, race/ethnicity, HBeAg status, antiviral treatment, HCV and HIV coinfection, diabetes, and alcohol use. Patients with cirrhosis or hepatocellular carcinoma (HCC) at base-line were excluded. Incidence of cirrhosis, hepatic decompensation, and HCC was estimated using competing risks Nelson-Aalen methods.

Among 27,548 veterans with CHB, only 16.1% underwent HDV testing. Of those tested, 3.25% were HDV positive. Testing rates were higher among patients who were HBeAg positive, on antiviral therapy, or identified as Asian or Pacific Islander.

Conversely, testing was significantly less common among patients with high-risk alcohol use, past or current drug use, cirrhosis at diagnosis, or HCV coinfection. In contrast, HIV coinfection was associated with increased odds of being tested.

Among those tested, HDV positivity was more likely in patients with HCV coinfection, cirrhosis, or a history of drug use. On multivariable analysis, these factors were independent predictors of HDV positivity.

In the matched cohort of 71 HDV-positive patients and 140 HDV-negative controls, the incidence of cirrhosis was more than 3-fold higher in HDV-positive patients (4.39 vs 1.30 per 100,000 person-years; P less than .01), and hepatic decompensation was over 5 times more common (2.18 vs 0.41 per 100,000 person-years; P = .01). There was also a non-significant trend toward increased HCC risk in the HDV group.

“These findings align with existing studies and confirm that among a predominantly non-Asian US cohort of CHB patients, presence of concurrent HDV is associated with more severe liver disease progression,” the investigators wrote. “These observations, taken together with the low rates of HDV testing overall and particularly among high-risk individuals, emphasizes the need for greater awareness and novel strategies on how to improve HDV testing and diagnosis, particularly given that novel HDV therapies are on the near horizon.”

The study was supported by Gilead. The investigators disclosed additional relationships with Exact Sciences, GSK, Novo Nordisk, and others.

Only 1 in 6 US veterans with chronic hepatitis B (CHB) is tested for hepatitis D virus (HDV)—a coinfection associated with significantly higher risks of cirrhosis and hepatic decompensation—according to new findings.

The low testing rate suggests limited awareness of HDV-associated risks in patients with CHB, and underscores the need for earlier testing and diagnosis, lead author Robert J. Wong, MD, of Stanford University School of Medicine, Stanford, California, and colleagues, reported.

“Data among US populations are lacking to describe the epidemiology and long-term outcomes of patients with CHB and concurrent HDV infection,” the investigators wrote in Gastro Hep Advances (2025 Oct. doi: 10.1016/j.gastha.2024.10.015).

Prior studies have found that only 6% to 19% of patients with CHB get tested for HDV, and among those tested, the prevalence is relatively low—between 2% and 4.6%. Although relatively uncommon, HDV carries a substantial clinical and economic burden, Dr. Wong and colleagues noted, highlighting the importance of clinical awareness and accurate epidemiologic data.

The present study analyzed data from the Veterans Affairs (VA) Corporate Data Warehouse between 2010 and 2023. Adults with CHB were identified based on laboratory-confirmed markers and ICD-9/10 codes. HDV testing (anti-HDV antibody and HDV RNA) was assessed, and predictors of testing were evaluated using multivariable logistic regression.

To examine liver-related outcomes, patients who tested positive for HDV were propensity score–matched 1:2 with CHB patients who tested negative. Matching accounted for age, sex, race/ethnicity, HBeAg status, antiviral treatment, HCV and HIV coinfection, diabetes, and alcohol use. Patients with cirrhosis or hepatocellular carcinoma (HCC) at base-line were excluded. Incidence of cirrhosis, hepatic decompensation, and HCC was estimated using competing risks Nelson-Aalen methods.

Among 27,548 veterans with CHB, only 16.1% underwent HDV testing. Of those tested, 3.25% were HDV positive. Testing rates were higher among patients who were HBeAg positive, on antiviral therapy, or identified as Asian or Pacific Islander.

Conversely, testing was significantly less common among patients with high-risk alcohol use, past or current drug use, cirrhosis at diagnosis, or HCV coinfection. In contrast, HIV coinfection was associated with increased odds of being tested.

Among those tested, HDV positivity was more likely in patients with HCV coinfection, cirrhosis, or a history of drug use. On multivariable analysis, these factors were independent predictors of HDV positivity.

In the matched cohort of 71 HDV-positive patients and 140 HDV-negative controls, the incidence of cirrhosis was more than 3-fold higher in HDV-positive patients (4.39 vs 1.30 per 100,000 person-years; P less than .01), and hepatic decompensation was over 5 times more common (2.18 vs 0.41 per 100,000 person-years; P = .01). There was also a non-significant trend toward increased HCC risk in the HDV group.

“These findings align with existing studies and confirm that among a predominantly non-Asian US cohort of CHB patients, presence of concurrent HDV is associated with more severe liver disease progression,” the investigators wrote. “These observations, taken together with the low rates of HDV testing overall and particularly among high-risk individuals, emphasizes the need for greater awareness and novel strategies on how to improve HDV testing and diagnosis, particularly given that novel HDV therapies are on the near horizon.”

The study was supported by Gilead. The investigators disclosed additional relationships with Exact Sciences, GSK, Novo Nordisk, and others.

Only 1 in 6 US veterans with chronic hepatitis B (CHB) is tested for hepatitis D virus (HDV)—a coinfection associated with significantly higher risks of cirrhosis and hepatic decompensation—according to new findings.

The low testing rate suggests limited awareness of HDV-associated risks in patients with CHB, and underscores the need for earlier testing and diagnosis, lead author Robert J. Wong, MD, of Stanford University School of Medicine, Stanford, California, and colleagues, reported.

“Data among US populations are lacking to describe the epidemiology and long-term outcomes of patients with CHB and concurrent HDV infection,” the investigators wrote in Gastro Hep Advances (2025 Oct. doi: 10.1016/j.gastha.2024.10.015).

Prior studies have found that only 6% to 19% of patients with CHB get tested for HDV, and among those tested, the prevalence is relatively low—between 2% and 4.6%. Although relatively uncommon, HDV carries a substantial clinical and economic burden, Dr. Wong and colleagues noted, highlighting the importance of clinical awareness and accurate epidemiologic data.

The present study analyzed data from the Veterans Affairs (VA) Corporate Data Warehouse between 2010 and 2023. Adults with CHB were identified based on laboratory-confirmed markers and ICD-9/10 codes. HDV testing (anti-HDV antibody and HDV RNA) was assessed, and predictors of testing were evaluated using multivariable logistic regression.

To examine liver-related outcomes, patients who tested positive for HDV were propensity score–matched 1:2 with CHB patients who tested negative. Matching accounted for age, sex, race/ethnicity, HBeAg status, antiviral treatment, HCV and HIV coinfection, diabetes, and alcohol use. Patients with cirrhosis or hepatocellular carcinoma (HCC) at base-line were excluded. Incidence of cirrhosis, hepatic decompensation, and HCC was estimated using competing risks Nelson-Aalen methods.

Among 27,548 veterans with CHB, only 16.1% underwent HDV testing. Of those tested, 3.25% were HDV positive. Testing rates were higher among patients who were HBeAg positive, on antiviral therapy, or identified as Asian or Pacific Islander.

Conversely, testing was significantly less common among patients with high-risk alcohol use, past or current drug use, cirrhosis at diagnosis, or HCV coinfection. In contrast, HIV coinfection was associated with increased odds of being tested.

Among those tested, HDV positivity was more likely in patients with HCV coinfection, cirrhosis, or a history of drug use. On multivariable analysis, these factors were independent predictors of HDV positivity.

In the matched cohort of 71 HDV-positive patients and 140 HDV-negative controls, the incidence of cirrhosis was more than 3-fold higher in HDV-positive patients (4.39 vs 1.30 per 100,000 person-years; P less than .01), and hepatic decompensation was over 5 times more common (2.18 vs 0.41 per 100,000 person-years; P = .01). There was also a non-significant trend toward increased HCC risk in the HDV group.

“These findings align with existing studies and confirm that among a predominantly non-Asian US cohort of CHB patients, presence of concurrent HDV is associated with more severe liver disease progression,” the investigators wrote. “These observations, taken together with the low rates of HDV testing overall and particularly among high-risk individuals, emphasizes the need for greater awareness and novel strategies on how to improve HDV testing and diagnosis, particularly given that novel HDV therapies are on the near horizon.”

The study was supported by Gilead. The investigators disclosed additional relationships with Exact Sciences, GSK, Novo Nordisk, and others.