Safety and Efficacy of Healthy to Inflamed Pouch Fecal Microbiota Transplantation
The purpose of this research study is to assess the safety and efficacy of fecal microbiota transplant (FMT) in the treatment of chronic pouchitis.
⁃ 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