Clinical trial No longer in our active list Early Phase 1 Interventional Ages 25 to 65

Effects of Saccharomyces Boulardii on Gut Barrier Function

Official title: Effects of Saccharomyces Boulardii CNCM I-745 on Intestinal Barrier Function

Run by Mayo Clinic · NCT05538247 · Data updated 2026-05-14

This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.

This study is testing if taking a probiotic called Saccharomyces boulardii can help healthy adults keep their gut barrier strong when taking a common pain reliever that can cause gut issues.

Quick facts

PhaseEarly Phase 1
Study typeInterventional
Ages25 Years to 65 Years
SexAll
Enrollment56 (estimated)
SponsorMayo Clinic
Academic / other
Locations1 site (Rochester, Minnesota)
Trial IDNCT05538247 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are healthy adults aged 18 to 35 with a BMI between 18 and 35 kg/m².

Probably not a fit

Patients with pre-existing gastrointestinal disorders or those not meeting the health criteria may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the impact of oral supplementation with Saccharomyces boulardii CNCM I-745 on intestinal barrier function in healthy adults. Participants will receive either the probiotic or a placebo while being administered indomethacin to induce temporary intestinal permeability. The study aims to determine if the probiotic can mitigate the effects of NSAID-induced hyperpermeability. It is a placebo-controlled, parallel group study designed to assess the primary outcome of intestinal permeability improvement.

Why it matters

Potential benefit: If successful, this study could lead to new strategies for enhancing gut health and preventing gastrointestinal issues related to impaired barrier function.

How similar studies have gone: Previous studies have shown promise in using probiotics for gut health, but this specific approach with S. boulardii CNCM I-745 is novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
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 immediately prior to starting the study treatment;
  * Agreement to comply with approved methods of contraception during the whole study: unless they meet the criteria of post-menopausal; i.e., 12 months of spontaneous amenorrhea, women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner, should use one or more of the following acceptable methods of contraception that should be maintained throughout the study:
  * Surgical sterilization;
  * Hormonal contraception (implantable, patch, oral, intra-muscular);
  * Intra-uterine device;
  * Double barrier method (diaphragm plus condom);
  * At the discretion of the investigator, total abstinence is acceptable in cases where age, career, lifestyle, or sexual orientation of the patient ensures compliance.

Exclusion Criteria:

* History of hypersensitivity to the study treatments (active substance or excipients), brewer's or baker's yeast.
* Contraindication and special warning to the study treatments according to the Summary of Product Characteristics (SmPCs).
* History of chronic constipation with passage of fewer than 3 spontaneous bowel movements per week on average.
* History of chronic or recurrent diarrhea with spontaneous unformed bowel movements equivalent to or more often than 3 times daily.
* Prior gastrointestinal surgery (apart from appendectomy or cholecystectomy performed at least more than one year ago).
* History of Clostridium difficile infection.
* Active gastrointestinal disease.
* Known chronic or recurrent systemic disorder (including diabetes and hypertension) that may interfere with the study treatment evaluation.
* Associated immune deficiency.
* Severe hepatic or renal impairment.
* Clinically relevant abnormalities in results of laboratory tests as per Investigator's judgement.
* Patients with a central venous catheter.
* Oral or systemic antibacterial therapy during the 3 months prior to study enrollment.
* NSAIDs and proton pump inhibitor treatment longer than 1 week, within 3 months prior to study enrollment.
* Steroids within 6 weeks prior to study enrollment.
* Use of medications affecting gastrointestinal transit or permeability within 7 days prior to the testing.
* Use of artificial sweeteners, lactulose, mannitol within 2 days prior to the testing and during the 24 h testing period.
* New prescription medications during the 2 weeks prior to study enrollment.
* Use of probiotics or drugs that alters gut microbiota or function, during 4 weeks prior to study enrollment.
* Intake of antifungals within 14 days prior to study enrollment.
* Substantial changes in eating habits within 30 days prior to receiving the first dose of IMP product, as assessed by the Investigator.
* Current smoker.
* History or presence of drug or alcohol abuse.
* Inability to abstain from intensive muscular effort the day before the intestinal permeability test.
* Breast-feeding woman.
* Patients enrolled in another clinical trial within the past 30 days.
* Patients not able to fill in the study questionnaires.
* Any condition or personal circumstance that, in the opinion of the investigator, renders the subject unlikely or unable to comply with the full study protocol.

Where it's running

  • Mayo Clinic
    Rochester, Minnesota, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.