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Fecal Microbiota Transplant for Patients With Chronic Pouchitis

RecruitingEarly phase 1

Safety and Efficacy of Healthy to Inflamed Pouch Fecal Microbiota Transplantation

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
Inclusion Criteria:

Patients age 18 or greater with UC who have undergone TPC with IPAA and have one of the following chronic pouchitis phenotypes, each defined as:

* Chronic antibiotic dependent pouchitis:
* The need for continuous antibiotic therapy (\>4 weeks) to maintain clinical remission and a history of at least 2 attempts in the last 24 months to stop antibiotic therapy resulting in pouchitis episodes, OR
* Active pouchitis with a modified Pouchitis Disease Activity Index (mPDAI) ≥5 and a history of ≥4 antibiotic therapies in the last 12 months
* Chronic antibiotic refractory pouchitis:
* Active pouchitis with a modified Pouchitis Disease Activity Index (mPDAI) ≥5 with no response to antibiotics
* Crohn's disease like pouch inflammation on biologic or small molecule therapy with persistent symptoms:
* Pre-pouch ileal inflammation, strictures, and/or fistulae, AND
* Active biologic or small molecule therapy, AND
* Persistent symptoms with mPDAI clinical sub-score ≥ 2

Exclusion Criteria:

Patients with UC who underwent TPC with IPAA and meet one of the following criteria will be excluded:

* Allergy to vancomycin, metronidazole, or ingredients present in the FMT
* Women who are breastfeeding
* Women who are pregnant
* Participants with fever \> 100.4F/38C or other signs of active illness
* Active treatment with biologics (infliximab, adalimumab, golimumab, vedolizumab, ustekinumab)
* Active treatment with immunomodulators (azathioprine, 6-mercaptopurine, methotrexate), steroids or any investigational drugs
* Crohn's disease like pouch inflammation
* Active enteric infection
* Isolated cuffitis
* Clinically significant strictures of the pouch inlet or outlet
* Participation in a clinical trial in the preceding 30 days
* Any condition that the physician investigators deems unsafe, including other conditions or medications that the investigator determines will put the participant at greater risk from FMT

About the study

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

What is being tested

Sponsor: Maia Kayal · Participants: 16 · Started: Oct 3, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT05829109

Locations in the U.S.

New YorkIcahn School of Medicine at Mount Sinai, New York

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.