Fecal Microbiota Transplantation for IBS

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Madhusudan (Madhu) Grover, MBBS
Study ID
NCT05776914
Phase
PHASE2
Status
Recruiting
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Conditions

  • Diarrhea
  • Irritable Bowel Syndrome

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Donor Fecal Microbiota Transplantation — BIOLOGICAL
    Single fecal microbiota transplantation using 50 gm of freeze-thawed donor stool
  • Autologous Fecal Microbiota Transplantation — BIOLOGICAL
    Single fecal microbiota transplantation using 50 gm of stool collected from the same individual

Study Details

The purpose of this study is to learn the efficacy and safety of fecal microbiota transplantation (FMT) using stool from a donor with low proteolytic activity and containing the bacteria Alistipes putredinis in patients with irritable bowel syndrome (IBS) and high proteolytic activity. Proteolytic activity is the breakdown of proteins into smaller polypeptides or amino acids.

Key Dates

Start date
Apr 15, 2024
Status verified
May 2026
Primary completion
Jun 26, 2027
Completion
Jun 26, 2027

Study Design

Enrollment
43 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Donor Fecal Microbiota Transplantation Group
    Subjects will receive a fecal microbiota transplantation (FMT) using stool from a donor
  • Placebo Comparator: Autologous Fecal Microbiota Transplantation Group
    Subjects will receive a fecal microbiota transplantation (FMT) using their own stool

Primary Outcome Measure

Percentage of responders [ Time Frame: 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in MinnesotaRochesterMinnesota55905-

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By research site
Mayo Clinic in Minnesota· Rochester, MN

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