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

2026-03-02
Frontiers in medicine 13

PubMed: 41852522
DOI: 10.3389/fmed.2026.1737537

Study Design

Type: Review
Population: 305 interventional 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.

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.

Research Insights

Supplement	Dose	Health Outcome	Effect Type	Effect Size	Source
Bifidobacterium plantarum	—	Improved Irritable Bowel Syndrome Symptoms	Beneficial	Moderate	View source Systematically analyze the global landscape of interventional clinical trials on gut microbiota modulation (GMM) therapies for irritable bowel syndrome (IBS)... Probiotics led (single-strain: Lactobacillus/Bifidobacterium; multi-strain: Lactobacillus + Bifidobacterium)...