Fecal Microbiota Transplant for Patients With Chronic Pouchitis

• Status: Not yet recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Maia Kayal

Criteria

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