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Fecal microbiota transplant (UTHealth Houston) is an investigational live biotherapeutic product developed by The University of Texas Health Science Center at Houston (UTHealth) for the treatment of recurrent Clostridioides difficile-associated diarrhea (CDAD). The active ingredient is processed fecal microbiota from healthy, screened donors. [2, 14] Its mechanism of action is the restoration of healthy gut microbiome diversity, which has been disrupted by the infection and antibiotic treatments, thereby outcompeting the pathogenic bacteria. [2, 10] This biologic therapy is being investigated in multiple formulations, including fresh, frozen, and lyophilized (freeze-dried) preparations, which are administered via colonoscopy, retention enema, or as oral capsules. [2, 3, 6] The product is being developed under FDA IND #17059 and has been studied in Phase 1/2 clinical trials. [3]
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