Saccharomyces Boulardii CNCM I-745 in Irritable Bowel Syndrome
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBiocodex
About this trial
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
Eligibility criteria
Qualifiers
Male or female aged ≥ 18 and ≤ 65 years.
Diagnosis of IBS of any subtype, except constipation predominant (IBS-C), according to Rome IV criteria.
IBS-SSS total score ≥ 175 at inclusion.
Able and willing to maintain their nutrition habits throughout the study participation.
Disqualifiers
Diagnosis of IBS-C according to Rome IV criteria.
Patient with more than 5 bowel movements per day on average during the screening period, according to the patient's diary (BSFS).
Severe illness(es) or medical condition(s), including gastrointestinal pathologies (other than IBS): gastrointestinal ulcers, coeliac disease, inflammatory bowel disease, bowel cancer, acute or chronic diarrhea secondary to confirmed infectious gastroenteritis, or enteral or parenteral nutrition.
History of abdominal surgery (except for appendectomy, cholecystectomy, surgery for hemorrhoids or cesarian section, more than 6 months prior to inclusion).
Trial design
Treatments tested in this trial
- Saccharomyces Boulardii 250 MG
- Placebo 250 mg
Treatment groups
406 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov