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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Saccharomyces Boulardii 250 MG
DrugSaccharomyces boulardii CNCM I-745, 250 mg, 2 capsules/day
Placebo 250 mg
DrugPlacebo, 250mg, 2 capsules/day
Treatment groups
406 Participants
are divided into 2 treatment groupsGroup A: TreatmentExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
To 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 56Secondary outcomes
1
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 842
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 843
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 baseline4
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 84Other outcomes
1
To explore the proportion of responders in Irritable Bowel Syndrome - with predominant Diarrhea (IBS-D) subgroup, according to the US Food and Drug Administration (FDA) definition.
Proportion of responders in Irritable Bowel Syndrome - with predominant Diarrhea (IBS-D) subgroup (Rome IV criteria at inclusion), according to the FDA definition (≥30% improvement in abdominal pain and a ≥50% reduction in number of days per week with at least one stool that has a consistency of type 6 or 7 on the Bristol Stool Form Scale (BSFS)) at D56 and D84 compared with baseline. The abdominal pain score will be taken from the abdominal pain 11-point numerical rating scale (NRS).
Time frame
Day 56 and day 84 compared with baseline2
To explore the proportion of patients who improved ≥ 75 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
Day 56 compared to baseline3
To explore the effect of Saccharomyces boulardii CNCM I-745 on each Irritable Bowel Syndrome- Quality of Life (IBS-QOL) subscore in comparison to placebo.
Change from baseline in Irritable Bowel Syndrome- Quality of Life (IBS-QOL)subscores (Dysphoria, Interference with activity, Body Image, Health worry, Food avoidance, Social Reaction, Sexual, and Relationships) at D56 and D84. Minimum score is 0 : poor quality of life. Maximum score : 100 : better quality of life.
Time frame
Day 56 and day 84 compared to baseline Source ClinicalTrials.gov