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Saccharomyces Boulardii CNCM I-745 in Irritable Bowel Syndrome

NCT07168434 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 406

Last updated 2025-11-18

No results posted yet for this study

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

Interventions

DRUG

Saccharomyces Boulardii 250 MG

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

DRUG

Placebo 250 mg

Placebo, 250mg, 2 capsules/day

Sponsors & Collaborators

  • Biocodex

    lead INDUSTRY

Principal Investigators

  • Oana Bernard, DR · Biocodex

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-22
Primary Completion
2026-10-11
Completion
2026-10-11

Countries

  • Portugal
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07168434 on ClinicalTrials.gov