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 eventsPlaceboPUNCH CD3-OLS: a phase 3 prospective observational cohort study to evaluate the safety and efficacy of fecal microbiota, live-jslm (REBYOTA) in adults with recurrent Clostridioides difficile infection
Feuerstadt P, Chopra T, Knapple W, Van Hise N, Dubberke E, Baggott B, Guthmueller B, Bancke L, Gamborg M, Steiner T, Van Handel D, Khanna S. PUNCH CD3-OLS: a phase 3 prospective observational cohort study to evaluate the safety and efficacy of fecal microbiota, live-jslm (REBYOTA) in adults with recurrent Clostridioides difficile infection. Clinical Infectious Diseases 2024, ciae437. PMID: 39180326, DOI: 10.1093/cid/ciae437.Peer-Reviewed Original ResearchTreatment-emergent adverse eventsRecurrent Clostridioides difficile infectionPreventing recurrent Clostridioides difficile infectionStandard-of-careSerious treatment-emergent adverse eventsTreatment successSustained clinical response ratesStandard-of-care antibioticsSustained clinical responseClinical response rateOpen-label studyTreatment success rateClostridioides difficile infectionMicrobiota-basedBaseline characteristic subgroupsObservational cohort studyFood and Drug AdministrationInflammatory bowel diseaseAntibiotic completionClinical responseSingle-doseEfficacy ratePrimary endpointSecondary endpointsImmunocompromised conditionsCorrection to: Efficacy and Practical Implementation of Fecal Microbiota Spores, Live-BRPK: A Novel Approach for Preventing Recurrent Clostridioides difficile Infection
Feuerstadt P, LaPlante K. Correction to: Efficacy and Practical Implementation of Fecal Microbiota Spores, Live-BRPK: A Novel Approach for Preventing Recurrent Clostridioides difficile Infection. The American Journal Of Gastroenterology 2024, 119: 1949-1949. PMID: 38180907, DOI: 10.14309/ajg.0000000000002649.Peer-Reviewed Original ResearchEfficacy and Practical Implementation of Fecal Microbiota Spores, Live-BRPK: A Novel Approach for Preventing Recurrent Clostridioides difficile Infection
Feuerstadt P, LaPlante K. Efficacy and Practical Implementation of Fecal Microbiota Spores, Live-BRPK: A Novel Approach for Preventing Recurrent Clostridioides difficile Infection. The American Journal Of Gastroenterology 2024, 119: s22-s26. PMID: 38153222, DOI: 10.14309/ajg.0000000000002582.Peer-Reviewed Original ResearchConceptsRecurrent Clostridioides difficile infectionClostridioides difficile infectionDifficile infectionRetrospective 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 rate366. Association Between Gut Microbiota and Health-Related Quality of Life in Patients with Recurrent Clostridioides difficile Infection: Results from the PUNCH CD3 Clinical Trial
Feuerstadt P, Blount K, Guo A, Yang M, García-Horton V, Fillbrunn M, Tillotson G, Gao Y, Dubberke E, Garey K. 366. Association Between Gut Microbiota and Health-Related Quality of Life in Patients with Recurrent Clostridioides difficile Infection: Results from the PUNCH CD3 Clinical Trial. Open Forum Infectious Diseases 2023, 10: ofad500.436. PMCID: PMC10676825, DOI: 10.1093/ofid/ofad500.436.Peer-Reviewed Original ResearchClostridioides difficile infectionGut microbiomeDifficile infectionFerring PharmaceuticalsGut microbiotaSignificant associationRecurrent Clostridioides difficile infectionBaseline patient characteristicsHealth-related qualityMicrobiota dataHealthy gut microbiomeSocial domain scoresQuality of lifeGrant/research supportAnalysis groupBackground RecurrencePatient characteristicsClinical trialsHRQLPatientsWeek 1Domain scoresMixed effects analysisHealthy microbiomeRCDI