2024
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 eventsPlaceboIntegrated 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 comorbiditiesRCDIWeeksAntibioticsPatientsComorbiditiesEfficacyPlaceboMicrobiomeRetrospective subgroup analysis of fecal microbiota, live-jslm (REBYOTA®) administered by colonoscopy under enforcement discretion for the prevention of recurrent Clostridioides difficile infection
Knapple W, Yoho D, Sheh A, Thul J, Feuerstadt P. Retrospective subgroup analysis of fecal microbiota, live-jslm (REBYOTA®) administered by colonoscopy under enforcement discretion for the prevention of recurrent Clostridioides difficile infection. Therapeutic Advances In Gastroenterology 2024, 17: 17562848241239547. PMID: 38529070, PMCID: PMC10962041, DOI: 10.1177/17562848241239547.Peer-Reviewed Original ResearchClostridioides difficile</i> infectionSustained clinical responseClinical responsePrevention of recurrent CDITreatment successRecurrent Clostridioides difficile infectionConsistent with clinical trialsAlternative routes of administrationRetrospective subgroup analysisClostridioides difficile infectionReal-world safetyRoute of administrationFood and Drug AdministrationAnalysis of fecal microbiotaCDI recurrenceSingle-doseFecal microbiotaDifficile infectionAdverse eventsRetrospective analysisLive biotherapeutic productsColonoscopyDrug AdministrationClinical interestTEAEs
2023
Fecal Microbiota, Live-jslm for the Prevention of Recurrent Clostridioides difficile Infection
Feuerstadt P, Crawford C, Tan X, Pokhilko V, Bancke L, Ng S, Guthmueller B, Bidell M, Tillotson G, Johnson S, Skinner A. Fecal Microbiota, Live-jslm for the Prevention of Recurrent Clostridioides difficile Infection. Journal Of Clinical Gastroenterology 2023, 58: 818-824. PMID: 38019088, PMCID: PMC11305620, DOI: 10.1097/mcg.0000000000001947.Peer-Reviewed Original ResearchWashout periodDouble-blind treatment periodTreatment-emergent adverse eventsRecurrent Clostridioides difficile infectionFecal microbiotaTreatment success rateInfection risk factorsTreatment-related variablesClostridioides difficile infectionTreatment effect sizeVancomycin coursesCDI episodesAdverse eventsDifficile infectionSubgroup analysisAntibiotic treatmentRisk factorsTreatment periodHigh riskMost subgroupsUS FoodDrug AdministrationRCDITreatment differencesSuccess rate