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Fecal microbiota transplant (FMT) is an investigational live biotherapeutic product developed by Massachusetts General Hospital for the treatment of Clostridium difficile infection (CDI). The therapy involves transferring fecal matter from a healthy, screened donor to a patient to restore a healthy gut microbiome. [3, 4] The product is prepared as a frozen inoculum, which can be administered via orally-ingested capsules, nasogastric tube, or colonoscopy. [3, 5] Clinical studies have evaluated its safety and efficacy in treating recurrent or refractory CDI, with trials exploring different delivery methods and dosing schedules. [2, 5, 9] The underlying mechanism is the reconstitution of normal gut flora, which helps to suppress the pathogenic C. difficile and resolve the infection and associated diarrhea. [3]
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