NCT05509725

Efficacy and Safety of a Probiotic Formulation in Adults With Irritable Bowel Syndrome With Diarrhea (IBS-D)

Efficacy and Safety of a Probiotic Formulation in Adults With Irritable Bowel Syndrome With Diarrhea (IBS-D): A Multicenter, Randomized, Prospective, Placebo-Controlled, Double-Blind, Phase IV Clinical Study

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 162 (estimated)
• Sponsor: Lallemand Health Solutions · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to monitor safety and to evaluate the efficacy of a probiotic formulation on abdominal pain, abnormal defecation, comorbid mood disorders (anxiety and depression) as well as general quality of life in adults with IBS-D.

Detailed description

To monitor safety and to evaluate the efficacy of a probiotic formulation on severity of gastrointestinal symptoms (abdominal pain, abnormal defecation), anxiety, depression and quality of life in adult participants with IBS-D.

Conditions

• IBS - Irritable Bowel Syndrome

Interventions

Type	Name	Description
DRUG	Probiotic formulation	Participants will be asked to take 2 doses daily
DRUG	Placebo	Participants will be asked to take 2 doses daily

Timeline

• Start date: 2022-08-11
• Primary completion: 2024-11-01
• Completion: 2024-11-01
• First posted: 2022-08-22
• Last updated: 2024-02-20

Locations

1 site across 1 country: Turkey (Türkiye)