REVIEW article
Front. Med.
Sec. Gastroenterology
This article is part of the Research TopicHarnessing the Gut Microbiome: Paving the Way for Personalized Treatment of Diverse DisordersView all articles
Global Landscape Analysis of Clinical Trials on Gut Microbiota Modulation Therapies for Irritable Bowel Syndrome
Provisionally accepted
- 1North Sichuan Medical College, Nanchong, China
- 2Faculty of Dentistry, The University of Hong Kong, Hong Kong, China
- 3Yantai Yuhuangding Hospital Affiliated to Medical College of Qingdao, Yantai, China
- 4Affiliated Hospital of North Sichuan Medical University, Nanchong, China
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Objective: Systematically analyze the global landscape of interventional clinical trials on Gut Microbiota Modulation (GMM) therapies for Irritable Bowel Syndrome (IBS). Methods: Searched the Trialtrove database (1998 – July 2025) with the key term combination "(Disease is Autoimmune/Inflammation: Irritable Bowel Syndrome) AND (Mechanism Of Action: Microbiome modulator)", included 305 interventional trials (excluded 15 observational studies). Descriptive analysis was done via SPSS 26.0, adhering to TITAN Guidelines 2025. Results: Asia was the most active region; trials peaked in 2021, with Phase II (44.3%) and IV (33.3%) dominant. Probiotics led (single-strain: Lactobacillus/Bifidobacterium; multi-strain: Lactobacillus+Bifidobacterium), followed by fecal microbiota transplantation (FMT). IBS-D (49.6%) was the main subtype (IBS-C: 26.1%); probiotics were the most frequently studied for both, FMT for IBS-D, and prebiotics for IBS-C. Conclusion: GMM therapies for IBS are relatively mature. Personalized therapies are necessary; multiomics and emerging therapies (e.g., Akkermansia muciniphila) will promote IBS precision medicine.
Keywords: clinical trial landscape, fecal microbiota transplantation, Gut Microbiota, Irritable Bowel Syndrome, Probiotics
Received: 02 Nov 2025; Accepted: 27 Jan 2026.
Copyright: © 2026 Luo, Cao, Li, Wang, Geng, Luo and Xie. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence:
Junwen Wang
Tianxiang Geng
Zining Luo
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