Fecal Microbiota Transplant for Patients With Chronic Pouchitis
Study Phase: Early Phase 1
Recruitment Status: Recruiting
Start Date: September 01, 2024
End Date: June 01, 2025
The purpose of this research study is to assess the safety and efficacy of fecal microbiota transplant (FMT) in the treatment of chronic pouchitis.
Inclusion Criteria: Patients age 18 or greater with UC who have undergone restorative proctocolectomy with ileal pouch anal anastomosis and have:
- Chronic antibiotic dependent pouchitis: 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
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
- Subjects 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 subject at greater risk from FMT
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Conditions:
- Pouchitis