NCT06346847

Study to Assess Effects of Postbiotic vs Placebo in Participants With Diarrhea-predominant IBS

A Randomized, Double Blind, Placebo Controlled, Parallel Group Clinical Study to Assess Effects of Postbiotic vs. Placebo in Participants With Moderate to Severe Diarrhea-predominant Irritable Bowel Syndrome

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 384 (actual)
• Sponsor: A-Mansia Biotech S.A. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The present study is a randomized, double-blind, placebo-controlled, parallel group clinical study that assesses the effect of postbioc on the complaints of subjects with moderate to severe diarrhoea-predominant irritable bowel syndrome (IBS-D). The trial is also evaluating the potential of postbiotic on anxiety, low mood and stress of the participants, as well as its safety and tolerability. The intervention duration for all the study participants is 12 weeks (intervention phase). Subsequently, the participants will be invited to return to site for an end of study assessment after 21 days of no intervention (post-intervention phase).

Conditions

• Diarrhea-Predominant Irritable Bowel Syndrome

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Postbiotic	1 capsule a day, 15 minutes before breakfast with a glass of water for 12 weeks
DIETARY_SUPPLEMENT	Placebo	1 capsule a day, 15 minutes before breakfast with a glass of water for 12 weeks

Timeline

• Start date: 2024-07-18
• Primary completion: 2025-05-29
• Completion: 2025-07-13
• First posted: 2024-04-04
• Last updated: 2026-03-23

Locations

23 sites across 1 country: India