Fecal Microbiota Transplant for Patients With Chronic Pouchitis

Launched by MAIA KAYAL · Apr 12, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called fecal microbiota transplant (FMT) for patients with chronic pouchitis, a condition that can occur after surgery for ulcerative colitis. The main goal is to find out if FMT is safe and effective for helping people who have to rely on antibiotics to manage their pouchitis symptoms. If you're at least 18 years old and have had surgery for ulcerative colitis, you might be eligible to participate, especially if you've been experiencing ongoing pouchitis that requires long-term antibiotic treatment or if you have active pouchitis symptoms.

If you join the trial, you can expect to receive the fecal microbiota transplant, which involves transferring healthy bacteria from a donor's stool into your digestive system to help restore a balanced gut environment. The study is currently looking for participants, but there are certain criteria that could prevent someone from joining, like being pregnant, breastfeeding, or currently taking specific medications. It's important to talk with your healthcare provider to see if this trial might be a good option for you or someone you care about.

Gender

ALL

Eligibility 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