RecruitingEarly Phase 1NCT05829109

Fecal Microbiota Transplant for Patients With Chronic Pouchitis

Safety and Efficacy of Healthy to Inflamed Pouch Fecal Microbiota Transplantation


Sponsor

Maia Kayal

Enrollment

16 participants

Start Date

Sep 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Fecal Microbiota Transplant (FMT) for people with chronic pouchitis and pouchitis. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFecal Microbiota Transplant (FMT)

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.


Locations(1)

Icahn School of Medicine at Mount Sinai

New York, New York, United States

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NCT05829109


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