Recruiting
Early Phase 1

Fecal Microbiota Transplant

Sponsor:

Maia Kayal

Code:

NCT05829109

Conditions

Chronic Pouchitis

Pouchitis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Fecal Microbiota Transplant (FMT)

Study Details

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

Study ID

NCT05829109

Start date

Oct 3, 2024

Status verified date

Aug, 2026

Completion date

Sep, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

16 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Fecal Microbiota Transplant (FMT)

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

Interventions

Fecal 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.

Primary outcome measure

  • Number of patients with FMT related adverse events [ Time Frame: 8 weeks ]

Central Contacts and Locations

Central contacts

Locations

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Contacts

Principal Investigator:

Maia Kayal

More Information

Sponsor

Maia Kayal

Last update posted

Aug 17, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Maia Kayal on 2026-08-17.