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Saccharomyces Boulardii CNCM I-745 in Irritable Bowel Syndrome

Study acronym: BoWell Sb252
StatusRecruiting
PhasePhase 3
SponsorBiocodex
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated November 18, 2025 (before its estimated October 11, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 10
    • Start date changed from estimate of Sep 15, 2025 to Oct 22, 2025
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Biocodex
6 trials monitored
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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
Trial Details
NCT Number NCT07168434
Lead Sponsor Biocodex
Conditions
(from sponsor)		 IBS (Irritable Bowel Syndrome), IBS-D (Diarrhea-predominant), IBS, Mixed Symptoms
Related terms Ichthyosis Bullosa of Siemens, Irritable Bowel Syndrome
Enrollment 406 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov