UCRecruiting
Fecal Microbiota Transplant for Patients With Chronic Pouchitis
Early Phase 1 · Testing Fecal Microbiota Transplant (FMT) · 1 site · Maia Kayal
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Fecal Microbiota Transplant (FMT) (a drug) as a possible treatment. Condition(s) listed: Chronic Pouchitis and Pouchitis.
It is open-label: participants know what they are receiving.
Early Phase 1 studies are very small first studies in people, mainly checking safety and how the body handles a treatment.
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- 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
Plus 7 more requirement(s). There are also 13 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 16 participants are expected to take part.
- Start date: 2024-10-03.
- Main results expected around 2027-06 (estimate from the record).
- 1 study site listed (1 marked recruiting) in United States.
Main thing being measured
- Number of patients with FMT related adverse events (8 weeks)
In the researchers’ words
The purpose of this research study is to assess the safety and efficacy of fecal microbiota transplant (FMT) in the treatment of chronic pouchitis.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Early Phase 1 |
| Study type | Interventional |
| Conditions | Chronic Pouchitis; Pouchitis |
| Lead sponsor | Maia Kayal |
| Enrollment | 16 (estimated) |
| Start date | 2024-10-03 |
| Primary completion (est.) | 2027-06 |
| First posted | 2023-04-25 |
| Last updated | 2026-08-17 |
| Official title | Safety and Efficacy of Healthy to Inflamed Pouch Fecal Microbiota Transplantation |
| ClinicalTrials.gov ID | NCT05829109 |
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.
Full eligibility criteria (from the record)
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
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | New York, New York | United States | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.