Definition

An oral capsule formulation composed of frozen ready-to-use human fecal microbiota from screened, healthy donors with healthy gut microbiota, for the potential treatment of recurrent Clostridium difficile (C. difficile) infections. Upon oral administration of the fecal microbiota transplantation (FMT) capsule, the microbiota in the capsule populate the gastrointestinal (GI) tract. The transplanted microbiota allows re-population of the patient’s microbiome with diverse protective microorganisms that competitively exclude C. difficile. This prevents recurrent C. difficile infections.