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

Part of paid clinical trials in Redwood City, California.

Sponsor
Stanford University
Study ID
NCT07238790
Phase
EARLY_PHASE1
Status
Not Yet Recruiting

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Conditions

  • Diarrhea
  • IBS (Irritable Bowel Syndrome)

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • MITI-001 administration — DRUG
    A complex gut bacterial community (MITI-001) will be given endoscopically and orally

Study Details

While the pathophysiology of diarrhea-predominant irritable bowel syndrome (IBS-D) is complex and heterogeneous, dysbiosis of the gut microbiome is frequently observed, suggesting that a substantial subset of patients with irritable bowel syndrome (IBS) have symptoms that are initiated and/or perpetuated by a microbiome dysfunction. Successful randomized controlled trials (RCT) for IBS-D (Ford 2018; Black 2022) leveraging microbiome-targeted therapies (antibiotics or low microbiome fermentation diets) suggest the gut microbiome is at least partially involved in IBS symptoms. Furthermore, fecal microbiota transplantation (FMT) for patients with IBS-D has demonstrated promising results (El-Salhy 2020), supporting the possibility that altering the microbiome composition could ameliorate IBS-D symptoms. MITI-001 is a transplantable gut bacterial community composed of 157 live bacterial strains, encompassing 79 genera of commensal bacteria, that have been isolated from healthy donor stool, purified, and banked. The hypothesis of the proposed research is that MITI-001 can target the pathophysiologic lesion in a subset of IBS-D patients, restore the altered microbial metabolic process, and thus alleviate IBS-D symptoms.

Key Dates

Start date
Dec 31, 2025
Status verified
Nov 2025
Primary completion
Dec 31, 2028
Completion
Dec 31, 2030

Study Design

Enrollment
13 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Intervention arm (MITI-001)
    Dosed with MITI-001

Primary Outcome Measure

Determine the safety of MITI-001 in the participant population [ Time Frame: up to 90 days ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Stanford Digestive Health ClinicRedwood CityCalifornia94063-
Stanford UniversityStanfordCalifornia94305-

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By research site
Stanford Digestive Health Clinic· Redwood City, CAStanford University· Stanford, CA

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