Fecal Microbiota Transplant for Patients With Chronic Pouchitis

Description

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

Conditions

Chronic Pouchitis, Pouchitis

Study Overview

Study Details

Study overview

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

Safety and Efficacy of Healthy to Inflamed Pouch Fecal Microbiota Transplantation

Fecal Microbiota Transplant for Patients With Chronic Pouchitis

Condition
Chronic Pouchitis
Intervention / Treatment

-

Contacts and Locations

New York

Icahn School of Medicine at Mount Sinai, New York, New York, United States, 10029

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Chronic antibiotic dependent pouchitis: 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
  • * Allergy to vancomycin, metronidazole, or ingredients present in the FMT
  • * Women who are breastfeeding
  • * Women who are pregnant
  • * Subjects 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 subject at greater risk from FMT

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Maia Kayal,

Maia Kayal, MD, MS, PRINCIPAL_INVESTIGATOR, Icahn School of Medicine at Mount Sinai

Study Record Dates

2025-06