Saccharomyces Boulardii CNCM I-745 on Intestinal Barrier Function

NCT05538247 | Recruiting Early Phase 1 FDA Drug

• 1 other identifier: 22-003898
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (6)

• Permeability assays

  Change in intestinal permeability parameters urinary lactulose and 13C (13carbon) mannitol in 0-2 hrs, 2-8 hrs, 8-24 hr urine collection

  Baseline, 2 hrs, 8 hrs, 24 hours

• Change in serum zonulin

  Circulating zonulin will be measured by ELISA (Immundiagnostik AG) reported in ng/mL

  Baseline, after intervention approximately 14 days

• Change in serum claudin

  Serum Claudin 1, 2, 3, 4, 5 and 8 will be measured by ELISAs (Enzyme-Linked Immunosorbent Assay)

  Baseline, after intervention approximately 14 days

• Change in fecal calprotectin

  Measured by ELISAs (Enzyme-Linked Immunosorbent Assay) from fecal samples reported in micrograms per milligram (μg/g)

  Baseline, day 7 (+/-1), day 14 (+/-1) and day 20 (placebo group only)

• Change in serum C-reactive protein (CRP)

  Measured by immuno-turbidimetric assay on an automated clinical chemistry analyzer reported in mg/L

  Baseline, day 7 (+/-1), day 14 (+/-1) and day 20 (placebo group only)

• Change in Gastrointestinal Symptom Rating Scale (GSRS) scores

  Measured by validated disease-specific questionnaire Gastrointestinal Symptom Response Scale (GSRS) used to evaluate common symptoms of gastrointestinal disorders. 15-item self-reported questionnaire related to signs and symptoms experienced by the subject during the past week, each rated on a seven-point Likert scale from no discomfort (score = 1) to very severe discomfort (score = 7). Total score is comprised between 15 and 105;

  Baseline, day 7 (+/-1), day 14 (+/-1) and day 20 (placebo group only)

Study Arms (2)

S. boulardii CNCM I-745 Group

EXPERIMENTAL

Subjects will receive Indomethacin from day 2 to day 7 and S. boulardii CNCM I-745 from day 1 to day 14

Drug: Indomethacin; Dietary Supplement: S. boulardii CNCM I-745

Placebo Group

PLACEBO COMPARATOR

Subjects will receive Indomethacin from day 2 to day 7 and Placebo from day 1 to day 14

Drug: Indomethacin; Drug: Placebo

Interventions

Indomethacin DRUG

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

Placebo Group; S. boulardii CNCM I-745 Group

S. boulardii CNCM I-745 DIETARY_SUPPLEMENT

Two 250 mg capsules orally twice daily for 14 days

Also known as: Nonpathogenic yeast

S. boulardii CNCM I-745 Group

Placebo DRUG

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

Placebo Group

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Interventions

Indomethacin

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Michael Camilleri, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Monique Torres

CONTACT

507-538-6599; torres.monique@mayo.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 8, 2022
• First Posted: September 13, 2022
• Study Start: April 13, 2023
• Primary Completion: December 30, 2025
• Study Completion: March 31, 2026
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)