Integrated Safety and Efficacy Analyses of Phase 3 Trials of a Microbiome Therapeutic for Recurrent CDI
Kraft C, Sims M, Silverman M, Louie T, Feuerstadt P, Huang E, Khanna S, Berenson C, Wang E, Cohen S, Korman L, Lee C, Kelly C, Odio A, Cook P, Lashner B, Ramesh M, Kumar P, De A, Memisoglu A, Lombardi D, Hasson B, McGovern B, von Moltke L, Pardi D. Integrated Safety and Efficacy Analyses of Phase 3 Trials of a Microbiome Therapeutic for Recurrent CDI. Infectious Diseases And Therapy 2024, 13: 2105-2121. PMID: 38941068, PMCID: PMC11416444, DOI: 10.1007/s40121-024-01007-z.Peer-Reviewed Original ResearchTreatment-emergent adverse eventsPhase 3 trialRCDI rateAnalysis of treatment-emergent adverse eventsTreatment-related treatment-emergent adverse eventsStandard-of-care antibioticsHigh-risk patientsClostridioides difficile infectionPreventing rCDIRenal impairment/failureAbdominal painRecurrent CDIEfficacy analysisAdverse eventsTreatment-relatedPrevent recurrencePrevalent comorbiditiesRCDIWeeksAntibioticsPatientsComorbiditiesEfficacyPlaceboMicrobiomeThe 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