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RECRUITING
NCT07168434
PHASE3

Saccharomyces Boulardii CNCM I-745 in Irritable Bowel Syndrome

Sponsor: Biocodex

View on ClinicalTrials.gov

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

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

406

Start Date

2025-10-22

Completion Date

2026-10-11

Last Updated

2025-11-18

Healthy Volunteers

No

Interventions

DRUG

Saccharomyces Boulardii 250 MG

Saccharomyces boulardii CNCM I-745, 250 mg, 2 capsules/day

DRUG

Placebo 250 mg

Placebo, 250mg, 2 capsules/day

Locations (10)

Hospital de Braga

Braga, Portugal

Hospital da Luz

Lisbon, Portugal

Hospital Universitario Vall d'Hebron

Barcelona, Spain

Hospital Universitario de León

León, Spain

Hospital Universitario Gregorio Marañon & Centro de Salud Pavones

Madrid, Spain

Hospital Clínico San Carlos

Madrid, Spain

Hospital Universitario La Paz & Hospital Carlos III

Madrid, Spain

Hospital Universitario Costa del Sol

Marbella, Spain

Hospital Universitario Regional de Málaga

Málaga, Spain

Hospital Universitario Central de Asturias & Centro de Salud la Lila

Oviedo, Spain