# Global landscape analysis of clinical trials on gut microbiota modulation therapies for irritable bowel syndrome

## TL;DR

This paper analyzes global clinical trials on gut microbiota therapies for IBS, finding that Asia leads in research and probiotics are the most studied treatment.

## Contribution

The study provides a comprehensive global analysis of gut microbiota modulation therapies for IBS, identifying trends and gaps in clinical trial design.

## Key findings

- Asia is the most active region for gut microbiota modulation trials for IBS.
- Probiotics and fecal microbiota transplantation are the most studied therapies, with IBS-D being the most common subtype.
- Personalized therapies and multiomics are suggested to advance precision medicine for IBS.

## Abstract

Systematically analyze the global landscape of interventional clinical trials on gut microbiota modulation (GMM) therapies for irritable bowel syndrome (IBS).

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.

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.

GMM therapies for IBS are relatively mature. Personalized therapies are necessary; multiomics and emerging therapies (e.g., Akkermansia muciniphila) will promote IBS precision medicine.