RECRUITING

Fecal Microbiota Transplant for Patients With Chronic Pouchitis

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Safety and Efficacy of Healthy to Inflamed Pouch Fecal Microbiota Transplantation

Quick Facts

Study Start:2024-09

Study Completion:2025-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05829109

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Maia Kayal, MD, MS

CONTACT

212-241-0150

Maia.Kayal@mountsinai.org

Principal Investigator

Maia Kayal, MD, MS

PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Study Locations (Sites)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029

United States

Collaborators and Investigators

Sponsor: Maia Kayal

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09

Study Completion Date2025-06

Study Record Updates

Study Start Date2024-09

Study Completion Date2025-06

Terms related to this study

Additional Relevant MeSH Terms

Chronic Pouchitis
Pouchitis