2025
Safety and effectiveness of fecal microbiota, live-jslm (REBYOTA®) administered by colonoscopy for prevention of recurrent Clostridioides difficile infection: 8-week results from CDI-SCOPE, a single-arm, phase IIIb trial
Khanna S, Yoho D, Van Handel D, Clark B, Awad T, Guthmueller B, Armandi D, Knapple W, Safdar N, Baggott B, Simon K, Feuerstadt P. Safety and effectiveness of fecal microbiota, live-jslm (REBYOTA®) administered by colonoscopy for prevention of recurrent Clostridioides difficile infection: 8-week results from CDI-SCOPE, a single-arm, phase IIIb trial. Therapeutic Advances In Gastroenterology 2025, 18: 17562848251339697. PMID: 40321366, PMCID: PMC12049624, DOI: 10.1177/17562848251339697.Peer-Reviewed Original ResearchTreatment-emergent adverse eventsPhase IIIb trialAntibiotic treatmentPrevention of recurrent CDINo treatment emergent adverse eventsTreatment successRecurrent Clostridioides difficile infectionClostridioides difficile</i> infectionIntensive care unit admissionParticipation benefitsPrevent CDI recurrenceClostridioides difficile infectionRoute of administrationPhysicians' perceptionsPreventing rCDICDI recurrenceTreatment failureEligible adultsSecondary endpointsFecal microbiotaEffects of fecal microbiotaUnit admissionDifficile infectionAdverse eventsPhysician experience
2024
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 comorbiditiesRCDIWeeksAntibioticsPatientsComorbiditiesEfficacyPlaceboMicrobiome
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