NCT07168434

Saccharomyces Boulardii CNCM I-745 in Irritable Bowel Syndrome

A Double-blind, Randomized, Placebo-controlled, Multicenter Trial Evaluating the Efficacy and Safety of Saccharomyces Boulardii CNCM I-745 in Adult Patients With Non-constipated Irritable Bowel Syndrome

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 406 (estimated)
• Sponsor: Biocodex · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• IBS (Irritable Bowel Syndrome)
• IBS-D (Diarrhea-predominant)
• IBS, Mixed Symptoms

Interventions

Type	Name	Description
DRUG	Saccharomyces Boulardii 250 MG	Saccharomyces boulardii CNCM I-745, 250 mg, 2 capsules/day
DRUG	Placebo 250 mg	Placebo, 250mg, 2 capsules/day

Timeline

• Start date: 2025-10-22
• Primary completion: 2026-10-11
• Completion: 2026-10-11
• First posted: 2025-09-11
• Last updated: 2025-11-18

Locations

10 sites across 2 countries: Portugal, Spain