Fecal Microbiota Transplant for Patients With Chronic Pouchitis (NCT05829109) | Clinical Trial Compass
RecruitingEarly Phase 1
Fecal Microbiota Transplant for Patients With Chronic Pouchitis
United States16 participantsStarted 2024-09-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
Number of patients with FMT related adverse events