5 Gastroenterology Headlines You Missed in November 2025

November brought a wave of notable updates across gastroenterology, marked by regulatory milestones, evolving clinical guidance, and new research shaping patient care. The month opened with the US Food and Drug Administration’s first-ever approval of a treatment for irritable bowel syndrome with constipation (IBS-C) in children ≥ 7 years of age, followed quickly by 52-week safety findings presented at the 2025 North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN) Annual Meeting. Meanwhile, the American Gastroenterological Association released its updated living guideline for moderate-to-severely active Crohn’s disease, reflecting the rapid expansion of high-efficacy therapeutic options and emphasizing early intervention to optimize long-term outcomes.

Beyond treatment advances, new analyses highlighted areas where access to care and clinical tools still fall short, including geographic disparities in gastroenterology specialist availability and the subpar performance of large language models in providing dietary guidance for IBS.

Check out this November 2025 gastroenterology month in review for a recap of HCPLive’s coverage of the top GI news and research from the past few weeks:

FDA Approves Linaclotide (Linzess) Capsules for Pediatric IBS-C

On November 5, 2025, the FDA approved Ironwood Pharmaceuticals' linaclotide (Linzess) capsules for pediatric patients ≥ 7 years of age with IBS-C, making it the first treatment approved for IBS-C in this patient population. The decision was supported by extrapolation of efficacy from adequate and well-controlled studies in adults and a 12-week double-blind, randomized, parallel-group trial in pediatric patients 7-17 years of age who met modified Rome III criteria for child/adolescent IBS-C.

Related: Julie Khlevner, MD, AGAF, Reacts to the FDA Approval of Linaclotide for Pediatric IBS-C

AGA Releases Updated Clinical Crohn’s Disease Guideline Reflecting New Therapies

On November 20, 2025, the AGA released a living clinical practice guideline on the pharmacologic management of moderate-to-severely active Crohn’s disease, intended to support a comprehensive, patient-centered, evidence-based approach to managing this patient population. The document includes 16 recommendations emphasizing early use of high-efficacy therapies including infliximab, adalimumab, ustekinumab, risankizumab, mirikizumab, guselkumab, and upadacitinib over step-up treatment to improve patient outcomes.

NASPGHAN 2025: Newly-Approved Linaclotide's Long-Term Safety Data

At the 2025 North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN) Annual Meeting, 52-week data on linaclotide reaffirmed its safety and tolerability in pediatric patients aged 7 to 17 years with IBS-C following its FDA approval for this indication.

Geographic Disparities in GI Specialist Availability Suggest Limited Access to Care

New research sheds light on state- and local-level geographic disparities in the availability of gastroenterologist care, highlighting limited access to care in rural areas and areas with low household incomes relative to urban areas. Study findings point to substantial disparities in the availability of specialist care, particularly in the Midwest and Southwest regions and rural and impoverished areas, all of which had fewer gastroenterologists than patients with inflammatory bowel disease needing care.

AI Tools Fall Short for Dietary Recommendations for Managing IBS

Findings from a recent study suggest large language models (LLMs) like ChatGPT and Gemini are not sufficient tools for providing dietary recommendations for patients with IBS. In the study, while ChatGPT provided mostly compliant responses with current dietary guidelines for IBS, investigators emphasize the need for further model improvements before relying solely on LLMs in clinical nutrition practice, highlighting the importance of dietitians' recommendations and the collaboration between AI models and healthcare teams.

References

1. Brooks A. FDA Approves Linaclotide (Linzess) Capsules for Pediatric IBS-C. HCPLive. November 5, 2025. Accessed December 1, 2025.https://www.hcplive.com/view/fda-approves-linaclotide-linzess-capsules-for-pediatric-ibs-c

2. Brooks A. AGA Releases Updated Clinical Crohn’s Disease Guideline Reflecting New Therapies. HCPLive. November 20, 2025. Accessed December 1, 2025. https://www.hcplive.com/view/aga-releases-updated-clinical-crohn-disease-guideline-reflecting-new-therapies

3. Fitch J. NASPGHAN 2025: Newly-Approved Linaclotide's Long-Term Safety Data. HCPLive. November 6, 2025. Accessed December 1, 2025. https://www.hcplive.com/view/naspghan-2025-newly-approved-linaclotide-s-long-term-safety-data

4. Brooks A. Geographic Disparities in GI Specialist Availability Suggest Limited Access to Care. HCPLive. November 28, 2025. Accessed December 1, 2025. https://www.hcplive.com/view/geographic-disparities-gi-specialist-availability-suggest-limited-access-to-care

5. Brooks A. AI Tools Fall Short for Dietary Recommendations for Managing IBS. HCPLive. November 25, 2025. Accessed December 1, 2025. https://www.hcplive.com/view/ai-tools-fall-short-for-dietary-recommendations-for-managing-ibs