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Fecal microbiota transplant (FMT) is an investigational biologic therapy being evaluated for the treatment of chronic pouchitis in a Phase 1 clinical trial (NCT05829109). The study is led by Dr. Maia Kayal at the Icahn School of Medicine at Mount Sinai. This therapy involves the administration of fecal microbiota collected from healthy donors. A novel aspect of this particular study is that the donors are individuals with healthy ileal pouches, as opposed to donors with intact colons, which has been the standard in previous studies. The primary goal is to correct the dysbiosis (imbalance of gut bacteria) within the recipient's inflamed pouch by introducing a healthy pouch microbiome, thereby reducing inflammation associated with chronic pouchitis. Chronic pouchitis is an inflammatory condition that can affect patients with ulcerative colitis who have undergone a total proctocolectomy with ileal pouch-anal anastomosis.
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