Saccharomyces boulardii CNCM I-745 in Irritable Bowel Syndrome.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Biocodex

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

Trial duration

4 Sep 2025 → ongoing

Decision date (initial)

2025-08-07

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Biocodex

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Therapy, Efficacy

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 objectives 5

1. To evaluate the impact of Saccharomyces boulardii CNCM I-745 on quality of life of IBS patients in comparison to placebo.
2. To demonstrate the efficacy of Saccharomyces boulardii CNCM I-745 on global and individual IBS symptoms, measured by the IBS-SSS, at each time point, in comparison to placebo.
3. To evaluate the proportion of patients who improved ≥ 50 points on IBS-SSS.
4. To evaluate the proportion of responders according to the European Medicines Agency (EMA) definition, after 8 weeks of treatment.
5. To evaluate the safety profile and tolerability of Saccharomyces boulardii CNCM I-745 capsules 500 mg/d in IBS patients in comparison to placebo.

Conditions and MedDRA coding

Non-constipated Irritable Bowel Syndrome (IBS)

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

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

Exclusion criteria 24

1. Diagnosis of IBS-C according to Rome IV criteria.
2. Patient with more than 5 bowel movements per day on average during the screening period, according to the patient’s diary (BSFS).
3. 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.
4. History of abdominal surgery (except for appendectomy, cholecystectomy, surgery for hemorrhoids or cesarian section, more than 6 months prior to inclusion).
5. Familial colorectal cancer syndrome (Lynch, Familial Adenomatous Polyposis).
6. Fecal transplant within 6 months prior to screening
7. 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.
8. Systemic antibiotic or antimycotic treatment within 2 weeks prior to randomization. These treatments are not allowed during the study.
9. 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.
10. 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
11. Use of opioids or narcotic analgesics, including tramadol and codeine, within 6 weeks prior to screening. These treatments are not allowed during the study.
12. 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
13. 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.
14. Allergy to yeast, especially Saccharomyces boulardii, or known hypersensitivity to one of the components.
15. Patients having a central venous catheter, critically ill patients, and immunocompromised patients.
16. Patients with rare hereditary problems of galactose or fructose intolerance, total lactase deficiency, glucose-galactose malabsorption or sucrase-isomaltase insufficiency.
17. Excessive alcohol consumption (>7 units/week) and/or drug abuse.
18. Other medical conditions or comorbidities, treatment, which in the opinion of the investigator, would interfere with study compliance or data interpretation.
19. Presenting any significant biological or clinical anomalies that are not compatible with participation in the study according to the investigator.
20. Participant at risk of pregnancy, pregnant or breastfeeding female.
21. Participant under guardianship or curatorship.
22. Participant under the protection of the Court or deprived of liberty.
23. 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.
24. Participant whose current state of health does not allow him/her to give consent.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Absolute change from baseline in IBS-SSS total score at 8 weeks (day 56 (D56)).

Secondary endpoints 5

1. Absolute change from baseline in Irritable Bowel Syndrome-Quality of Life (IBS- QOL) score at D56 and D84.
2. 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.
3. Proportion of responders defined as patients who improved ≥ 50 points on IBS-SSS at D28, D56 and D84 compared with baseline.
4. 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.
5. 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.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Auxiliary 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Biocodex

Sponsor organisation

Biocodex

Address

22 Rue Des Aqueducs

City

Gentilly

Postcode

94250

Country

France

Scientific contact point

Organisation

Biocodex

Contact name

Dounia HOUAMEL

Public contact point

Organisation

Biocodex

Contact name

Elise MICLOT

Third parties 2

Locations

2 EU/EEA countries · 14 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 40 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications