NCT05829109 · Maia Kayal
Fecal Microbiota Transplant for Patients With Chronic Pouchitis
What this study is about
The purpose of this research study is to assess the safety and effectiveness of fecal microbiota transplant (FMT) in the treatment of chronic pouchitis.
View original scientific 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.
Interventions
DRUG
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 measures
Number of patients with FMT related adverse events
Time frame: 8 weeks
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- New York, New York
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 15, 2025 · Source of record for eligibility and locations