SACCHAROMYCES BOULARDII CNCM I-745 LYOPHILIZED for Irritable bowel syndrome (non-constipated)

Inclusion criteria

• {"criterion_text":"- Male or female aged ≥ 18 and ≤ 65 years."}
• {"criterion_text":"- Diagnosis of IBS of any subtype, except constipation predominant (IBS-C), according to Rome IV criteria."}
• {"criterion_text":"- IBS-SSS total score ≥ 175 at inclusion."}
• {"criterion_text":"- Able and willing to maintain their nutrition habits throughout the study participation."}
• {"criterion_text":"- Able to understand and willing to comply with study requirements and to provide written informed consent."}
• {"criterion_text":"- For women of childbearing potential: willing to use one or more acceptable birth control method throughout the study participation."}

Exclusion criteria

• {"criterion_text":"- Diagnosis of IBS-C according to Rome IV criteria."}
• {"criterion_text":"- Daily or regular non-steroidal anti-inflammatory drugs (NSAIDS) at doses above cardiovascular prophylaxis (low dose aspirin) are not allowed within 2 weeks prior to screening and throughout the study participation"}
• {"criterion_text":"- Use of opioids or narcotic analgesics, including tramadol and codeine, within 6 weeks prior to screening. These treatments are not allowed during the study."}
• {"criterion_text":"- Treatment with two or more antidepressant/anxiolytic/antipsychotic within 3 months prior to study entry or during the trial. Treatment with a single antidepressant or anxiolytic or antipsychotic agent before and during the trial is allowed provided that the dose is stable within 3 months prior to study entry and during the trial participation"}
• {"criterion_text":"- Treatment with anticholinergics for overactive bladder such as solifenacin, darifenacin, oxybutynin, tolterodine, fesoterodin, propiverin, trospium chloride, or mirabegron, within 1 week prior to screening. These treatments are not allowed during the study."}
• {"criterion_text":"- Allergy to yeast, especially Saccharomyces boulardii, or known hypersensitivity to one of the components."}
• {"criterion_text":"- Patients having a central venous catheter, critically ill patients, and immunocompromised patients."}
• {"criterion_text":"- Patients with rare hereditary problems of galactose or fructose intolerance, total lactase deficiency, glucose-galactose malabsorption or sucrase-isomaltase insufficiency."}
• {"criterion_text":"- Excessive alcohol consumption (>7 units/week) and/or drug abuse."}
• {"criterion_text":"- Other medical conditions or comorbidities, treatment, which in the opinion of the investigator, would interfere with study compliance or data interpretation."}
• {"criterion_text":"- Presenting any significant biological or clinical anomalies that are not compatible with participation in the study according to the investigator."}
• {"criterion_text":"- Patient with more than 5 bowel movements per day on average during the screening period, according to the patient’s diary (BSFS)."}
• {"criterion_text":"- Participant at risk of pregnancy, pregnant or breastfeeding female."}
• {"criterion_text":"- Participant under guardianship or curatorship."}
• {"criterion_text":"- Participant under the protection of the Court or deprived of liberty."}
• {"criterion_text":"- Participant participating in another interventional clinical trial which could interfere with the trial’s results or impact the other trial’s results; or within 5 half-lives of the study investigational treatment, whichever is longer."}
• {"criterion_text":"- Participant whose current state of health does not allow him/her to give consent."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- History of abdominal surgery (except for appendectomy, cholecystectomy, surgery for hemorrhoids or cesarian section, more than 6 months prior to inclusion)."}
• {"criterion_text":"- Familial colorectal cancer syndrome (Lynch, Familial Adenomatous Polyposis)."}
• {"criterion_text":"- Fecal transplant within 6 months prior to screening"}
• {"criterion_text":"- Use of products marketed as prebiotics, probiotics or synbiotics within 2 weeks prior to screening. These products, with the exception of the investigational product, will not be allowed during the trial. Regular cheese or yogurt containing lactic acid bacteria are not an exclusion criterion."}
• {"criterion_text":"- Systemic antibiotic or antimycotic treatment within 2 weeks prior to randomization. These treatments are not allowed during the study."}
• {"criterion_text":"- Laxatives, antibloating agents, antidiarrheal medication, antispasmodics, within 2 weeks prior to screening. These treatments are not allowed during the study, except loperamide which can be used as rescue medication."}

Primary endpoints

• {"endpoint_text":"- Absolute change from baseline in IBS-SSS total score at 8 weeks (day 56 (D56)).","definition_or_measurement_approach":"Measured by the Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS); absolute change from baseline at day 56 (D56)."}

Secondary endpoints

• {"endpoint_text":"- Absolute change from baseline in Irritable Bowel Syndrome-Quality of Life (IBS- QOL) score at D56 and D84.","definition_or_measurement_approach":"Absolute change from baseline in IBS-QOL score at day 56 and day 84."}
• {"endpoint_text":"- Absolute change from baseline in IBS-SSS total score at D28 and D84. Absolute change from baseline in IBS-SSS subscores (abdominal pain, number of days with pain, abdominal distension, satisfaction with bowel habits, impact on life in general) at D56 and D84.","definition_or_measurement_approach":"Absolute change from baseline in IBS-SSS total and subscores at specified timepoints (D28, D56, D84); subscores include abdominal pain, days with pain, abdominal distension, satisfaction with bowel habits, impact on life."}
• {"endpoint_text":"- Proportion of responders defined as patients who improved ≥ 50 points on IBS-SSS at D28, D56 and D84 compared with baseline.","definition_or_measurement_approach":"Responder defined as improvement ≥50 points on IBS-SSS at D28, D56 and D84 versus baseline; proportion of such patients reported at each timepoint."}
• {"endpoint_text":"- Proportion of responders at D56 and D84 according to the EMA definition (patients with a subject’s global assessment of efficacy scale (IBS-GIS) of the highest two improvement grades of a 7-point scale, 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.","definition_or_measurement_approach":"EMA responder: IBS-GIS highest two improvement grades on 7-point scale AND ≥30% improvement in abdominal pain score from baseline (abdominal pain measured using 11-point NRS); assessed at D56 and D84."}
• {"endpoint_text":"- Adverse events and serious adverse events (number of events and number of participants with at least one event), changes in vital signs, body weight (quantitative statistics at each assessment time and changes from baseline), or resulting in the discontinuation of the study treatment.","definition_or_measurement_approach":"Safety endpoints include counts of adverse events/serious adverse events, number of participants with ≥1 event, changes in vital signs and body weight (quantitative statistics and change from baseline), and events leading to treatment discontinuation."}

Methods

• Marketing campaigns (K2_BoWell-Sb252_Marketing campaigns_IBS_Biocodex_ES_for pub) — country-specific marketing materials for Spain.
• PatientsUP platform materials (Clinical Trial Summary for Patients Up Platform, Prescreening_questionnaire, Terms and conditions, Participant flow, Marketing Images) — online prescreening and recruitment via PatientsUP platform (materials present for patient-facing recruitment).
• Recruitment materials: posters and flyers in Spanish and Portuguese (K2_BoWell-Sb252_Recruitment materials_Poster IBS_SP_for pub; K2_BoWell-Sb252_Recruitment materials_Flyer IBS_SP_for pub; K2_BoWell-Sb252_Recruitment materials_Poster_Flyer IBS_PT_for pub) — printed/digital materials for local site recruitment in Spain and Portugal.
• Recruitment arrangements and informed consent procedures documents (K1_BoWell-Sb252_Recruitment arrangements and IC procedures) — site-level recruitment and IC processes described for both Spain and Portugal.

Portugal

Earliest CTIS Part Ii Submission Date

18-07-2025

Latest Decision Or Authorization Date

23-12-2025

Processing Time Days

158

Number Of Sites

3

Number Of Participants

70

Spain

Earliest CTIS Part Ii Submission Date

11-08-2025

Latest Decision Or Authorization Date

21-01-2026

Processing Time Days

163

Number Of Sites

11

Number Of Participants

295

Primary sponsor

Full Name

Biocodex

Organisation Type

Pharmaceutical company

Country Of Registered Address

France

Contract research organisations

Name

Sermes CRO

Responsibilities

codes: 1,11,12,5

Third parties

• {"country":"France","full_name":"Exystat","duties_or_roles":"codes: 10","organisation_type":"Pharmaceutical company"}
• {"country":"Spain","full_name":"Sermes CRO","duties_or_roles":"codes: 1,11,12,5","organisation_type":"Pharmaceutical company"}