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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
406
Saccharomyces boulardii CNCM I-745, 250 mg, 2 capsules/day
Placebo, 250mg, 2 capsules/day
Hospital de Braga
Braga, Portugal
RECRUITINGHospital da Luz
Lisbon, Portugal
NOT_YET_RECRUITINGHospital Universitario Vall d'Hebron
Barcelona, Spain
NOT_YET_RECRUITINGHospital Universitario de León
León, Spain
RECRUITINGHospital Universitario Gregorio Marañon & Centro de Salud Pavones
Madrid, Spain
RECRUITINGHospital Clínico San Carlos
Madrid, Spain
NOT_YET_RECRUITINGHospital Universitario La Paz & Hospital Carlos III
Madrid, Spain
NOT_YET_RECRUITINGHospital Universitario Costa del Sol
Marbella, Spain
NOT_YET_RECRUITINGHospital Universitario Regional de Málaga
Málaga, Spain
NOT_YET_RECRUITINGHospital Universitario Central de Asturias & Centro de Salud la Lila
Oviedo, Spain
NOT_YET_RECRUITINGTo demonstrate the efficacy of Saccharomyces boulardii CNCM I-745 on global Irritable Bowel Syndrome (IBS) symptoms, measured by the Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS), in comparison to placebo after 8 weeks.
Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS) is a scale evaluating the severity of the disease from 0 (minimum score : not severe) to 500 (maximum score : severe).
Time frame: From baseline to day 56
To evaluate the impact of Saccharomyces boulardii CNCM I-745 on quality of life of Irritable Bowel Syndrome (IBS) patients in comparison to placebo.
Absolute change measured in the Irritable Bowel Syndrome-Quality of Life (IBS-QOL). Minimum score is 0 : poor quality of life. Maximum score : 100 : better quality of life.
Time frame: From baseline to day 56 and from baseline to day 84
To demonstrate the efficacy of Saccharomyces boulardii CNCM I-745 on global and individual Irritable Bowel Syndrome (IBS) symptoms, measured by the Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS), at each time point, in comparison to placebo.
Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS) is a scale evaluating the severity of the disease from 0 (minimum score : not severe) to 500 (maximum score : severe).
Time frame: From baseline to day 28, day 56 and day 84
To evaluate the proportion of patients who improved ≥ 50 points on Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS).
Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS) is a scale evaluating the severity of the disease from 0 (minimum score : not severe) to 500 (maximum score : severe).
Time frame: At day 28, day 56 and day 84 compared with baseline
To evaluate the proportion of responders according to the European Medicines Agency (EMA) definition, after 8 weeks of treatment
Proportion of responders at D56 and D84 according to the EMA definition (patients with a subject's global assessment of efficacy scale (Irritable Bowel Syndrome - Global Improvement Scale, IBS-GIS) of the highest two improvement grades of a 7-point scale (1 : significantly relieved to 7 : significantly worse), and with an abdominal pain score which has improved at least 30% compared to baseline). The abdominal pain score will be taken from the abdominal pain 11-point NRS.(0 : no pain to 10 : worse possible pain)
Time frame: Day 56 and day 84
Assessment of the safety and tolerability of Saccharomyces boulardii CNCM I-745. Irritable Bowel Syndrome (IBS) patients in comparison to placebo. Recording adverse events
Safety endpoint : Recording of adverse events and serious adverse events (number of events and number of participants with at least one event)
Time frame: From baseline to day 84
Assessment of the safety and tolerability of Saccharomyces boulardii CNCM I-745. Irritable Bowel Syndrome (IBS) patients in comparison to placebo. Recording changes in pulse rate
Safety endpoint : changes in pulse rate (beats per minute)
Time frame: From baseline to day 84
Assessment of the safety and tolerability of Saccharomyces boulardii CNCM I-745. Irritable Bowel Syndrome (IBS) patients in comparison to placebo. Recording changes in blood pressure
Safety endpoint : changes in blood pressure (millimeter of mercury (mmHg))
Time frame: From baseline to day 84
Assessment of the safety and tolerability of Saccharomyces boulardii CNCM I-745. Irritable Bowel Syndrome (IBS) patients in comparison to placebo. Recording changes in body weight
Safety endpoint : changes in body weight (kilograms (kg))
Time frame: From baseline to day 84
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