Condition: IBS (Irritable Bowel Syndrome) · IBS-D (Diarrhea-predominant) · IBS, Mixed Symptoms · Sponsor: Biocodex
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
This description comes directly from the study's public registry record.
Elise Miclot · +33 3 44 86 75 84 · e.miclot@biocodex.fr
Hugo-Miguel Dachez De Oliveira · +33344868228 · hm.dachezdeoliveira@biocodex.fr
Always discuss trial participation with your own doctor first.
| Hospital de Braga | Braga, Portugal | Recruiting |
| Hospital da Luz | Lisbon, Portugal | Not Yet Recruiting |
| Hospital Universitario Vall d'Hebron | Barcelona, Spain | Not Yet Recruiting |
| Hospital Universitario de León | León, Spain | Recruiting |
| Hospital Universitario Gregorio Marañon & Centro de Salud Pavones | Madrid, Spain | Recruiting |
| Hospital Clínico San Carlos | Madrid, Spain | Not Yet Recruiting |
| Hospital Universitario La Paz & Hospital Carlos III | Madrid, Spain | Not Yet Recruiting |
| Hospital Universitario Costa del Sol | Marbella, Spain | Not Yet Recruiting |
| Hospital Universitario Regional de Málaga | Málaga, Spain | Not Yet Recruiting |
| Hospital Universitario Central de Asturias & Centro de Salud la Lila | Oviedo, Spain | Not Yet Recruiting |
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Source record: clinicaltrials.gov/study/NCT07168434