SER-109 is an investigational microbiota-based product for fecal microbiota transplantation (FMT). It is proposed to prevent recurrent Clostridioides (formerly Clostridium) difficile infection (CDI) in adults with a history of 3 or more CDI episodes within a 9-month period. SER-109 is a purified suspension of approximately 50 species of Firmicutes spores derived from stool specimens from healthy donors. The product is prepared according to current Good Manufacturing Practices (cGMP) and is encapsulated for oral delivery.
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