Fecal Microbiota Transplant for Patients With Chronic Pouchitis

NCT05829109 | Recruiting Early Phase 1 DMC FDA Drug

• 1 other identifier: STUDY-22-01753
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Pouchitis; Pouchitis

Outcome Measures

Primary Outcomes (1)

• Number of patients with FMT related adverse events

  The number of patients with FMT related adverse events through week 8 classified according to the Medical Dictionary for Regulatory Activities (MedDRA) and categorized according to the NIH Criteria for Adverse Events.

  8 weeks

Secondary Outcomes (9)

• Number of patients in clinical remission

  8 weeks

• Number of patients with endoscopic response

  8 weeks

• Change in recipient fecal microbial diversity via metagenomics analysis

  Baseline and up to 8 weeks

• Change in recipient fecal microbial diversity via strain strain isolation

  Baseline and up to 8 weeks

• Change in recipient microbe tracking

  Baseline and up to 8 weeks

Study Arms (1)

Fecal Microbiota Transplant (FMT)

EXPERIMENTAL

Single arm of 16-18 subjects, all of whom will receive the interventional FMT.

Drug: Fecal Microbiota Transplant (FMT)

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.

Fecal Microbiota Transplant (FMT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maia Kayal: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

MeSH Terms

Conditions

Pouchitis

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Ileitis; Enteritis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Ileal Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Maia Kayal, MD, MS

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maia Kayal, MD, MS

CONTACT

212-241-0150; Maia.Kayal@mountsinai.org

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This will be a pilot study of 16-18 patients who will each receive FMT.

Study Record Dates

• First Submitted: March 30, 2023
• First Posted: April 25, 2023
• Study Start: September 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 15, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 9 months and ending 36 months following article publication.
• Access Criteria: Researchers who provide a methodologically sound proposal. For individual participant data meta-analysis. Proposals should be directed to Maia.Kayal@mountsinai.org. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (tbd).

Locations

US (1)