SER-109, an Oral Microbiome Therapy for Recurrent <i>Clostridioides difficile</i> Infection
Paul Feuerstadt, Thomas J. Louie, Bret Lashner, Elaine E.L. Wang, Liyang Diao, Jessica A. Bryant, Matthew Sims, Colleen S. Kraft, Stuart H. Cohen, Charles S. Berenson, Louis Y. Korman, Christopher B. Ford, Kevin D. Litcofsky, Mary-Jane Lombardo, Jennifer R. Wortman, Henry Wu, John G. Auniņš, Christopher W.J. McChalicher, Jonathan A. Winkler, Barbara H. McGovern, Michele Trucksis, Matthew R. Henn, Lisa von Moltke
Abstract
BACKGROUND: infection. METHODS: infection recurrence up to 8 weeks after treatment. Diagnosis by toxin testing was performed at trial entry, and randomization was stratified according to age and antibiotic agent received. Analyses of safety, microbiome engraftment, and metabolites were also performed. RESULTS: spore germination. CONCLUSIONS: infection after treatment with standard-of-care antibiotics, oral administration of SER-109 was superior to placebo in reducing the risk of recurrent infection. The observed safety profile of SER-109 was similar to that of placebo. (Funded by Seres Therapeutics; ECOSPOR III ClinicalTrials.gov number, NCT03183128.).