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This refers to a frozen fecal microbiota transplant (FMT) product developed and studied by researchers at McMaster University, led by Dr. Christine Lee, for the treatment of recurrent Clostridioides difficile infection (CDI). [6, 9] The active ingredient is a complex biological preparation of fecal microbiota from healthy, screened donors that is frozen and then thawed for administration. It acts as a biologic therapy by restoring the disrupted gut microbiota in patients with recurrent CDI, thereby preventing the overgrowth and recurrence of C. difficile. The transplant is administered through routes such as retention enema or colonoscopy. A Phase 2 open-label, single-arm trial evaluated the safety and efficacy of this frozen-and-thawed FMT approach.
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