Saccharomyces Boulardii CNCM I-745 in Irritable Bowel Syndrome

This is a double-blind, randomized (group assignment by chance), placebo-controlled, multicenter trial which will be conducted over a 13.5-months period The main objective of the research is to demonstrate the efficacy of Saccharomyces boulardii CNCM I-745 on global IBS symptoms, measured by the Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS), in comparison to placebo after 8 weeks. Secondary efficacy objectives are to evaluate the impact of Saccharomyces boulardii CNCM I-745 on quality of life of IBS patients and on global and individual IBS symptoms, using the IBS-SSS, in comparison to placebo at regular intervals over a 3-month treatment period. This research also aims to evaluate the proportion of patients who improved ≥ 50 points on IBS-SSS and the proportion of responders according to the European Medicines Agency (EMA) definition (based on the patient's global assessment of efficacy and on abdominal pain score), after 8 weeks of treatment. Secondary safety objective is to evaluate the safety profile and tolerability of Saccharomyces boulardii CNCM I-745 capsules 500 mg/day in IBS patients in comparison to placebo

NCT Number	NCT07168434
Lead Sponsor	Biocodex
Conditions	IBS (Irritable Bowel Syndrome), IBS-D (Diarrhea-predominant), IBS, Mixed Symptoms
Enrollment	406 participants
Start Date	2025-10-22
Primary Completion	2026-10-11 (estimated)
Study Completion	2026-10-11 (estimated)
Updated on ClinicalTrials.gov	2025-11-18