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Trial · NCT07168434

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 mai

Published on
Status
Recruiting
Sponsor
Biocodex
Study type
Interventional
Phase
Phase 3
Enrollment
406 participants (planned)
Start
Oct 22, 2025
Primary completion
Oct 11, 2026
Conditions
IBS (Irritable Bowel Syndrome), IBS-D (Diarrhea-predominant), IBS, Mixed Symptoms

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.

Interventions

  • Saccharomyces Boulardii 250 MG Drug
  • Placebo 250 mg Drug

Locations

2 countries: Portugal, Spain.

FacilityCityCountry
Hospital de BragaBragaPortugal
Hospital da LuzLisbonPortugal
Hospital Universitario Vall d'HebronBarcelonaSpain
Hospital Universitario de LeónLeónSpain
Hospital Universitario Gregorio Marañon & Centro de Salud PavonesMadridSpain
Hospital Clínico San CarlosMadridSpain
Hospital Universitario La Paz & Hospital Carlos IIIMadridSpain
Hospital Universitario Costa del SolMarbellaSpain
Hospital Universitario Regional de MálagaMálagaSpain
Hospital Universitario Central de Asturias & Centro de Salud la LilaOviedoSpain

View on ClinicalTrials.gov

TreatIBS is an informational site and does not provide medical advice. The research summarized here may not apply to your situation. Talk with a clinician before starting, stopping, or changing any treatment.

Listing only. Eligibility is decided by the study team. TreatIBS is not involved in recruitment.