Safety and Tolerability of CP101, a full spectrum, oral microbiome therapeutic for the prevention of recurrent C. difficile infection: A Phase 2 Randomized Controlled Trial.
Allegretti J, Kelly C, Louie T, Fischer M, Hota S, Misra B, Van Hise N, Yen E, Bullock J, Silverman M, Davis I, McGill S, Pardi D, Orenstein R, Grinspan A, El-Nachef N, Feuerstadt P, Borody T, Khanna S, Budree S, Kassam Z. Safety and Tolerability of CP101, a full spectrum, oral microbiome therapeutic for the prevention of recurrent C. difficile infection: A Phase 2 Randomized Controlled Trial. Gastroenterology 2024 PMID: 39366468, DOI: 10.1053/j.gastro.2024.09.030.Peer-Reviewed Original ResearchCDI recurrenceRecurrent Clostridioides difficile infectionClostridioides difficile infectionGroup compared to placeboStandard-of-careWeek 8Preventing recurrent Clostridioides difficile infectionReduce recurrent Clostridioides difficile infectionSafety profile similar to placeboRecurrent C. difficile infectionIncidence of adverse eventsPlacebo-controlled trialPrevention of recurrent C. difficile infectionPhase 2 randomized controlled trialMicrobiome therapeuticsToxin EIADouble-blindEfficacy endpointPCR-based testsDiagnostic modalitiesOral doseDifficile infectionProportion of participantsAdverse eventsPlaceboThe Progression of Microbiome Therapeutics for the Management of Gastrointestinal Diseases and Beyond
Allegretti J, Khanna S, Mullish B, Feuerstadt P. The Progression of Microbiome Therapeutics for the Management of Gastrointestinal Diseases and Beyond. Gastroenterology 2024, 167: 885-902. PMID: 38754739, DOI: 10.1053/j.gastro.2024.05.004.Peer-Reviewed Original ResearchFecal microbiota transplantationMicrobiome therapeuticsNext generation sequencingIntestinal ecosystemHuman microbiotaMicrobiota restorationGeneration sequencingGastrointestinal microbiomeMicrobiota transplantationMicrobiotaExtraintestinal conditionsMitigate diseaseIncreased abilityEcosystemMicrobiomeTherapeuticsGastrointestinal diseasesSequence