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Saccharomyces Boulardii CNCM I-745 on Intestinal Barrier Function

NCT05538247 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2026-05-11

No results posted yet for this study

Summary

This study is being done to assess the effects of S. boulardii CNCM I-745 compared to placebo on impaired intestinal permeability, which is the control of material passing from inside the gastrointestinal tract through the cells lining the gut wall into the rest of the body.

Conditions

  • Healthy

Interventions

DRUG

Indomethacin

Immediate release oral capsules 50 mg, 3 times a day for 6 days

DIETARY_SUPPLEMENT

S. boulardii CNCM I-745

Two 250 mg capsules orally twice daily for 14 days

DRUG

Placebo

Two 250 mg capsules that contains no active study ingredient orally twice daily for 14 days

Sponsors & Collaborators

Principal Investigators

  • Michael Camilleri, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-04-13
Primary Completion
2025-12-30
Completion
2026-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

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 NCT05538247 on ClinicalTrials.gov