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Probiotic

Probiotics for Healthy Subjects

Phase < 1
Recruiting
Led By Michael Camilleri, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, day 7 (+/-1), day 14 (+/-1) and day 20 (placebo group only)
Awards & highlights

Study Summary

This trial is testing a probiotic to see if it can help people with intestinal permeability, or 'leaky gut.'

Who is the study for?
Healthy adults with a BMI of 18-35 kg/m^2 and weight over 50 kg can join. Women who can get pregnant must test negative for pregnancy and agree to use contraception. Participants should have regular bowel movements, not be in another trial recently, or have taken certain drugs that affect the gut.Check my eligibility
What is being tested?
The study tests if S. boulardii CNCM I-745 improves intestinal barrier function compared to placebo in healthy people. It also looks at how indomethacin affects this process by possibly impairing the gut lining's control of material passage into the body.See study design
What are the potential side effects?
Possible side effects may include hypersensitivity reactions due to yeast intolerance, digestive disturbances from probiotics or indomethacin, such as bloating or gas, and other common drug-related adverse events.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, day 7 (+/-1), day 14 (+/-1) and day 20 (placebo group only)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, day 7 (+/-1), day 14 (+/-1) and day 20 (placebo group only) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Gastrointestinal Symptom Rating Scale (GSRS) scores
Body Weight Changes
Change in serum C-reactive protein (CRP)
+3 more

Side effects data

From 2012 Phase 3 trial • 630 Patients • NCT00033917
9%
decreased urine output
4%
excessive bleeding
3%
ischemic changes by ECHO
2%
creatinine > 1.8 mg/dL
1%
necrotizing enterocolitis
1%
platelets < 50,000
100%
80%
60%
40%
20%
0%
Study treatment Arm
IVH Negative Indomethacin
IVH Negative Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: S. boulardii CNCM I-745 GroupExperimental Treatment2 Interventions
Subjects will receive Indomethacin from day 2 to day 7 and S. boulardii CNCM I-745 from day 1 to day 14
Group II: Placebo GroupPlacebo Group2 Interventions
Subjects will receive Indomethacin from day 2 to day 7 and Placebo from day 1 to day 14
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Indomethacin
2011
Completed Phase 4
~4130

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,212 Previous Clinical Trials
3,766,982 Total Patients Enrolled
Michael Camilleri, MDPrincipal InvestigatorMayo Clinic
38 Previous Clinical Trials
3,216 Total Patients Enrolled

Media Library

S. boulardii CNCM I-745 (Probiotic) Clinical Trial Eligibility Overview. Trial Name: NCT05538247 — Phase < 1
Healthy Subjects Research Study Groups: S. boulardii CNCM I-745 Group, Placebo Group
Healthy Subjects Clinical Trial 2023: S. boulardii CNCM I-745 Highlights & Side Effects. Trial Name: NCT05538247 — Phase < 1
S. boulardii CNCM I-745 (Probiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05538247 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible to join this clinical experiment at the present moment?

"Clinicaltrials.gov reports that this research project is no longer recruiting applicants, having first been posted on December 15th 2022 and last amended November 3rd 2022. Nonetheless, there are still 839 other studies welcoming volunteers at the moment."

Answered by AI

Am I eligible to contribute to this research endeavor?

"This clinical trial is accepting applicants aged 25 to 65 who fit the criteria of healthy subjects (hs). Moreover, in order for participants to be eligible they must possess a BMI between 18 and 35 kg/m^2, weigh more than 50 kg at screening, give consent prior to beginning any procedures associated with study, yield negative results from a urine pregnancy test conducted before treatment begins, have undergone surgical sterilization or another form of contraception like hormonal implantation or an intra-uterine device. In addition this group must also demonstrate regular defecation patterns which include three bowel movements each week."

Answered by AI

Does this research encompass participants aged 70 and older?

"This medical research is recruiting participants aged 25 or older but younger than 65 years old."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Saccharomyces Boulardii CNCM I-745 on Intestinal Barrier Function
Michael Camilleri, MD 2023. "Saccharomyces Boulardii CNCM I-745 on Intestinal Barrier Function". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05538247.
~21 spots leftby Nov 2024
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