Fecal Microbiota Transplant for Patients With Chronic Pouchitis

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 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

Conditions:
• Pouchitis