Fecal Microbiota Transplant for Patients With Chronic Pouchitis

Part of paid clinical trials in New York, New York.

Sponsor
Maia Kayal
Study ID
NCT05829109
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Chronic Pouchitis
  • Pouchitis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Fecal Microbiota Transplant (FMT) — DRUG
    The intervention consists of the following steps: * Step 1: Vancomycin 125 mg orally every 6 hours and metronidazole 250 mg orally every 6 hours for 5 days. * Step 2: Bowel preparation with 10 ounces of magnesium citrate. * Step 3: Two FMT doses will be administered via enema one week apart using stool from donors with a durably healthy pouch.

Study Details

The purpose of this research study is to assess the safety and efficacy of fecal microbiota transplant (FMT) in the treatment of chronic pouchitis.

Key Dates

Start date
Sep 1, 2024
Status verified
Jul 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

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

Arms

  • Experimental: Fecal Microbiota Transplant (FMT)
    Single arm of 16-18 subjects, all of whom will receive the interventional FMT.

Primary Outcome Measure

Number of patients with FMT related adverse events [ Time Frame: 8 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Icahn School of Medicine at Mount SinaiNew YorkNew York10029
Maia Kayal, MD, MS
[email protected]
212-241-0150
Maia Kayal (PRINCIPAL_INVESTIGATOR)

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By research site
Icahn School of Medicine at Mount Sinai· New York, NY

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