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This investigational fecal microbiota transplantation (FMT) product, developed by the Memorial University of Newfoundland, is an oral, encapsulated formulation of live commensal bacteria derived from healthy donor stool. Unlike traditional FMT, which is typically reserved for recurrent *Clostridium difficile* infections and administered via invasive routes, this specific product is being evaluated in Phase 3 clinical trials as a primary (first-line) therapy for *Clostridium difficile*-associated diarrhea (CDAD). The treatment aims to rapidly restore the diversity and functional integrity of the gut microbiome, which is often depleted by antibiotic use. By reintroducing a complex microbial ecosystem, the therapy provides colonization resistance against *C. difficile* through nutrient competition, niche exclusion, and the restoration of secondary bile acid metabolism, which inhibits the germination and vegetative growth of the pathogen.
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