Saccharomyces Boulardii CNCM I-745 in Irritable Bowel Syndrome
Recruiting
Phase 3
Interventional Study
IBS (Irritable Bowel Syndrome)
IBS-D (Diarrhea-predominant)
IBS, Mixed Symptoms
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 65
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 406 (estimated)
- Sponsor
- Biocodex · Industry
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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.
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Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Male or female aged ≥ 18 and ≤ 65 years.
2. Diagnosis of IBS of any subtype, except constipation predominant (IBS-C), according to Rome IV criteria.
3. IBS-SSS total score ≥ 175 at inclusion.
4. Able and willing to maintain their nutrition habits throughout the study particip…
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