Saccharomyces Boulardii CNCM I-745 in Irritable Bowel Syndrome

NCT07168434 | Recruiting Phase 3

• 2 other identifiers: BoWell Sb2522024-520276-10-00
• Study Type: interventional
• Target: 406
• Locations: 2 countries
• Sites: 10

Brief Summary

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

Conditions

IBS (Irritable Bowel Syndrome); IBS-D (Diarrhea-predominant); IBS, Mixed Symptoms

Keywords

IBS; Irritable Bowel Syndrome; Saccharomyces boulardii; Non-constipated IBS

Outcome Measures

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).

  From baseline to day 56

Secondary Outcomes (8)

• To evaluate the impact of Saccharomyces boulardii CNCM I-745 on quality of life of Irritable Bowel Syndrome (IBS) patients in comparison to placebo.

  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.

  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).

  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

  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

  From baseline to day 84

Other Outcomes (3)

• 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.

  Day 56 and day 84 compared with baseline

• To explore the proportion of patients who improved ≥ 75 points on Irritable Bowel Syndrome Symptom Severity Scale(IBS-SSS).

  Day 56 compared to baseline

• 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.

  Day 56 and day 84 compared to baseline

Study Arms (2)

Treatment

EXPERIMENTAL

Saccharomyces boulardii CNCM I-745, 250 mg, 2 capsules/day

Drug: Saccharomyces Boulardii 250 MG

Placebo

PLACEBO COMPARATOR

Placebo, 250mg, 2 capsules/day

Drug: Placebo 250 mg

Interventions

Saccharomyces Boulardii 250 MG DRUG

Saccharomyces boulardii CNCM I-745, 250 mg, 2 capsules/day

Treatment

Placebo 250 mg DRUG

Placebo, 250mg, 2 capsules/day

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.
• Familial colorectal cancer syndrome (Lynch, Familial Adenomatous Polyposis).
• Fecal transplant within 6 months prior to screening.
• Systemic antibiotic or antimycotic treatment within 2 weeks prior to randomization. These treatments are not allowed during the study.
• 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.
• 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.
• Use of opioids or narcotic analgesics, including tramadol and codeine, within 6 weeks prior to screening. These treatments are not allowed during the study.
• 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.
• 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.
• Allergy to yeast, especially Saccharomyces boulardii, or known hypersensitivity to one of the components.
• Patients having a central venous catheter, critically ill patients, and immunocompromised patients.
• Patients with rare hereditary problems of galactose or fructose intolerance, total lactase deficiency, glucose-galactose malabsorption or sucrase-isomaltase insufficiency.
• Excessive alcohol consumption (\>7 units/week) and/or drug abuse.

Sponsors & Collaborators

• Biocodex: lead

Study Sites (10)

Hospital de Braga

Braga, Portugal

RECRUITING

Hospital da Luz

Lisbon, Portugal

NOT YET RECRUITING

Hospital Universitario Vall d'Hebron

Barcelona, 08035, Spain

NOT YET RECRUITING

Hospital Universitario de León

León, 24008, Spain

RECRUITING

Hospital Universitario Gregorio Marañon & Centro de Salud Pavones

Madrid, 28007, Spain

RECRUITING

Hospital Clínico San Carlos

Madrid, 28040, Spain

NOT YET RECRUITING

Hospital Universitario La Paz & Hospital Carlos III

Madrid, 28046, Spain

NOT YET RECRUITING

Hospital Universitario Costa del Sol

Marbella, 29603, Spain

NOT YET RECRUITING

Hospital Universitario Regional de Málaga

Málaga, 29010, Spain

NOT YET RECRUITING

Hospital Universitario Central de Asturias & Centro de Salud la Lila

Oviedo, 33011, Spain

NOT YET RECRUITING

MeSH Terms

Conditions

Irritable Bowel Syndrome; Ichthyosis Bullosa of Siemens

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Ichthyosis; Skin Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Genetic Diseases, Inborn; Infant, Newborn, Diseases; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Oana Bernard, DR

  Biocodex

  STUDY DIRECTOR

Central Study Contacts

Elise Miclot

CONTACT

+33 3 44 86 75 84; e.miclot@biocodex.fr

Hugo-Miguel Dachez De Oliveira

CONTACT

+33344868228; hm.dachezdeoliveira@biocodex.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2025
• First Posted: September 11, 2025
• Study Start: October 22, 2025
• Primary Completion (Estimated): October 11, 2026
• Study Completion (Estimated): October 11, 2026
• Last Updated: November 18, 2025

Record last verified: 2025-11

Locations

PT (2); ES (8)