Effects of Saccharomyces Boulardii CNCM I-745 on Intestinal Barrier Function
Mayo Clinic
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.
Description
This placebo-controlled parallel group clinical study in healthy adults from the general population aims to investigate whether oral supplementation with S. boulardii CNCM I-745 could strengthen the intestinal barrier function and counteract the acute NSAID-induced hyperpermeability. Indomethacin will be used short term to increase intestinal permeability. The primary objective of the study is to assess the effects of S. boulardii CNCM I-745 on this impaired intestinal permeability.
Eligibility
- Age range
- 25–65 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Considered as healthy after a comprehensive clinical assessment (detailed medical history and complete physical examination). * With a body mass index (BMI) comprised between 18 and 35 kg/m\^2 and weight \> 50 kg at Screening. * Able to comply with study requirements and to provide signed informed consent. * Has signed the informed consent form before beginning any study procedure. * Regular defecation (frequency and stool consistency, with at least about three bowel movements a week). * For women of childbearing potential: * A negative urine pregnancy test immediatel…
Interventions
- DrugIndomethacin
Immediate release oral capsules 50 mg, 3 times a day for 6 days
- Dietary SupplementS. boulardii CNCM I-745
Two 250 mg capsules orally twice daily for 14 days
- DrugPlacebo
Two 250 mg capsules that contains no active study ingredient orally twice daily for 14 days
Location
- Mayo ClinicRochester, Minnesota