Fecal Microbiota Transplant for Patients With Chronic Pouchitis
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMaia Kayal
About this trial
The purpose of this research study is to assess the safety and efficacy of fecal microbiota transplant (FMT) in the treatment of chronic pouchitis.
Eligibility criteria
Qualifiers
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
Active pouchitis with a modified Pouchitis Disease Activity Index (mPDAI) ≥5 with no response to antibiotics
Pre-pouch ileal inflammation, strictures, and/or fistulae, AND
Disqualifiers
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
Trial design
Treatments tested in this trial
- Fecal Microbiota Transplant (FMT)
Treatment groups
16 Participants
are divided into 1 treatment groupSponsors and collaborators
Maia Kayal
Lead sponsor
Icahn School of Medicine at Mount Sinai
Sponsor institution
Source ClinicalTrials.gov