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Study of MITI-001 for Irritable Bowel Syndrome with Diarrhea (IBS-D)

This study is looking at a treatment called MITI-001 for people with Irritable Bowel Syndrome with Diarrhea (IBS-D). MITI-001 is a special mix of gut bacteria that will be given to you through an endoscopy (a procedure where a thin, flexible tube with a camera is used to look inside your body) and also by mouth. Researchers want to see if MITI-001 is safe for people to use. You might be able to join if you are between 18 and 65 years old, have IBS-D, and show signs of microbiome dysfunction, such as certain levels of bile acids in your stool or a positive breath test. The study is currently unclear about its recruitment status.

Study design
This is an interventional study with a planned enrollment of 13 participants. The phase of the study is not specified.
What's involved
MITI-001 will be administered endoscopically and orally. The safety of MITI-001 will be measured for up to 90 days.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for safety for up to 90 days after receiving MITI-001.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07238790

Use of A Complex Gut Bacterial Consortium (MITI 001) for the Treatment of Irritable Bowel Syndrome With Diarrhea

Not Yet Recruiting
EARLY_PHASE1Ages 18–65InterventionalTreatment
Stanford University
~13 participants
Updated 2025-11-20 on ClinicalTrials.gov
What's tested:MITI-001 administration

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Determine the safety of MITI-001 in the participant population
Measured over up to 90 days

Conditions

IBS (Irritable Bowel Syndrome)
Diarrhea

Explore related trials

Irritable Bowel SyndromeHydrogen breath testPrimary bile acid

Where it's being run

2 sites across 1 states
California2

Study leadership

  • Michael Fischbach, PhD · STUDY_DIRECTOR · Stanford University
  • Sean P Spencer, MD, PhD · PRINCIPAL_INVESTIGATOR · Stanford University

Who to contact

Sean Assistant Professor of Medicine
[email protected]
6507365555
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Male participants with partners who are women of childbearing potential (WOCBP): Appropriate contraception includes condoms or other means considered adequate by the responsible Investigator.
Female participants who are WOCBP: Appropriate contraception includes condoms, an intrauterine device, hormonal contraception, or other means considered adequate by the responsible Investigator. 7. Capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol. 8. Able to tolerate the planned course of antibiotics, EGD, and colonoscopy with bowel lavage.

What this trial measures

  • Determine the safety of MITI-001 in the participant populationup to 90 days

    Incidence of MITI-001-related adverse events