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Saccharomyces Boulardii CNCM I-745 in Irritable Bowel Syndrome
Sponsor: Biocodex
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
Saccharomyces Boulardii 250 MG
Saccharomyces boulardii CNCM I-745, 250 mg, 2 capsules/day
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