HealthyEarly Phase 1NCT05538247
Saccharomyces Boulardii CNCM I-745 on Intestinal Barrier Function
A Early Phase 1 study testing Indomethacin and S. boulardii CNCM I-745 in people with Healthy, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Indomethacin and S. boulardii CNCM I-745
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Apr 2023to 31 Mar 2026
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Saccharomyces Boulardii CNCM I-745 on Intestinal Barrier Function
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.
Read the detailed 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.
- Conditions
- Healthy
- Being tested
- Indomethacin, S. boulardii CNCM I-745, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IndomethacinDrug
Immediate release oral capsules 50 mg, 3 times a day for 6 days
S. boulardii CNCM I-745Dietary supplement
Also called Nonpathogenic yeast
Two 250 mg capsules orally twice daily for 14 days
PlaceboDrug
Two 250 mg capsules that contains no active study ingredient orally twice daily for 14 days
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Indomethacin; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, 2 hrs, 8 hrs, 24 hours
Change in serum zonulin
Circulating zonulin will be measured by ELISA (Immundiagnostik AG) reported in ng/mL
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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;
Measured: Baseline, day 7 (+/-1), day 14 (+/-1) and day 20 (placebo group only)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2022
- Study start13 Apr 2023
- Primary completion30 Dec 2025
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Camilleri, MD, Mayo Clinic
- Investigators
- Michael Camilleri, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05538247
- Sponsor's protocol ID
- 22-003898
- Status last verified
- May 2026
- First submitted
- 8 Sep 2022
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Saccharomyces Boulardii CNCM I-745 on Intestinal Barrier Function
- ClinicalTrials.gov ID
- NCT05538247
- Acronym / sponsor ID
- 22-003898
- Conditions
- Healthy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 13 Apr 2023 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 13 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| S. boulardii CNCM I-745 Group | Experimental | Drug: Indomethacin, Dietary Supplement: S. boulardii CNCM I-745Subjects will receive Indomethacin from day 2 to day 7 and S. boulardii CNCM I-745 from day 1 to day 14 |
| Placebo Group | Placebo comparator | Drug: Indomethacin, Drug: PlaceboSubjects will receive Indomethacin from day 2 to day 7 and Placebo from day 1 to day 14 |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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).
Key exclusion criteria (28 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IndomethacinImmediate release oral capsules 50 mg, 3 times a day for 6 days | Drug | Placebo Group, S. boulardii CNCM I-745 Group |
| S. boulardii CNCM I-745Also: Nonpathogenic yeastTwo 250 mg capsules orally twice daily for 14 days | Dietary supplement | S. boulardii CNCM I-745 Group |
| PlaceboTwo 250 mg capsules that contains no active study ingredient orally twice daily for 14 days | Drug | Placebo Group |
Primary outcome
Permeability assays
Time frame: Baseline, 2 hrs, 8 hrs, 24 hours
Change in intestinal permeability parameters urinary lactulose and 13C (13carbon) mannitol in 0-2 hrs, 2-8 hrs, 8-24 hr urine collection
Change in serum zonulin
Time frame: Baseline, after intervention approximately 14 days
Circulating zonulin will be measured by ELISA (Immundiagnostik AG) reported in ng/mL
Change in serum claudin
Time frame: Baseline, after intervention approximately 14 days
Serum Claudin 1, 2, 3, 4, 5 and 8 will be measured by ELISAs (Enzyme-Linked Immunosorbent Assay)
Change in fecal calprotectin
Time frame: Baseline, day 7 (+/-1), day 14 (+/-1) and day 20 (placebo group only)
Measured by ELISAs (Enzyme-Linked Immunosorbent Assay) from fecal samples reported in micrograms per milligram (μg/g)
Change in serum C-reactive protein (CRP)
Time frame: Baseline, day 7 (+/-1), day 14 (+/-1) and day 20 (placebo group only)
Measured by immuno-turbidimetric assay on an automated clinical chemistry analyzer reported in mg/L
Change in Gastrointestinal Symptom Rating Scale (GSRS) scores
Time frame: Baseline, day 7 (+/-1), day 14 (+/-1) and day 20 (placebo group only)
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;
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Camilleri, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Indomethacin and S. boulardii CNCM I-745 in people with Healthy, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Permeability assays (time frame: Baseline, 2 hrs, 8 hrs, 24 hours). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.