2025
Efficacy and Safety of Fecal Microbiota Transplant for Prevention of Recurrent Clostridioides difficile Infection
Shaukat A, Drekonja D, Huang Y, Zhang J, Davis-Karim A, Kyriakides T. Efficacy and Safety of Fecal Microbiota Transplant for Prevention of Recurrent Clostridioides difficile Infection. Clinical Infectious Diseases 2025, ciaf142. PMID: 40260582, DOI: 10.1093/cid/ciaf142.Peer-Reviewed Original ResearchPrevention of recurrent CDISafety of fecal microbiota transplantationRecurrent Clostridioides difficile infectionClostridioides difficile infectionFecal microbiota transplantationMicrobiota transplantationSafety 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 experienceSafety and Efficacy of Fecal Microbiota, Live-jslm (REBYOTA®), for the Prevention of Recurrent Clostridioides difficile Infection in Participants With Inflammatory Bowel Disease in PUNCH CD3-OLS
Allegretti J, Feuerstadt P, Knapple W, Orenstein R, Pinton P, Sheh A, Khanna S. Safety and Efficacy of Fecal Microbiota, Live-jslm (REBYOTA®), for the Prevention of Recurrent Clostridioides difficile Infection in Participants With Inflammatory Bowel Disease in PUNCH CD3-OLS. Inflammatory Bowel Diseases 2025, izae291. PMID: 39862395, DOI: 10.1093/ibd/izae291.Peer-Reviewed Original ResearchTreatment-emergent adverse eventsRecurrent Clostridioides difficile infectionInflammatory bowel diseaseClostridioides difficile infectionWeeks of administrationPrevention of recurrent CDISerious treatment-emergent adverse eventsSubgroup analysisSustained clinical response ratesBowel diseaseSustained clinical responseClinical response rateModerate gastrointestinal symptomsUS Food and Drug AdministrationTreatment success rateFood and Drug AdministrationClinical responseSingle-doseProspective trialsFecal microbiotaEfficacy outcomesDifficile infectionAdverse eventsGastrointestinal symptomsTreatment success
2024
Safety and Tolerability of CP101, a Full-Spectrum, Oral Microbiome Therapeutic for the Prevention of Recurrent Clostridioides 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 Clostridioides difficile Infection: A Phase 2 Randomized Controlled Trial. Gastroenterology 2024, 168: 357-366.e3. 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 eventsPlaceboA Randomized Controlled Trial of Efficacy and Safety of Fecal Microbiota Transplant for Preventing Recurrent Clostridioides difficile Infection
Drekonja D, Shaukat A, Huang Y, Zhang J, Reinink A, Nugent S, Dominitz J, Davis-Karim A, Gerding D, Kyriakides T. A Randomized Controlled Trial of Efficacy and Safety of Fecal Microbiota Transplant for Preventing Recurrent Clostridioides difficile Infection. Clinical Infectious Diseases 2024, 80: 52-60. PMID: 39271107, DOI: 10.1093/cid/ciae467.Peer-Reviewed Original ResearchCDI recurrenceClostridioides difficile infectionFecal microbiota transplantationRecurrent Clostridioides difficile infectionAdverse eventsPreventing recurrent Clostridioides difficile infectionOral fecal microbiota transplantationMicrobiota transplantationCause of healthcare-associated infectionsSafety of fecal microbiota transplantationDouble-blind clinical trialTrials of efficacyHealthcare-Associated InfectionsStatistically significant differenceRandomized Controlled TrialsClinical recurrenceUnformed stoolsPlacebo armPlacebo capsulesPrimary endpointDifficile infectionRecurrent diarrheaAntibiotic treatmentVeterans Health Administration systemClinical trialsPUNCH 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, 80: 43-51. PMID: 39180326, PMCID: PMC11797394, 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 ResearchCharacteristics of Patients With Initial Clostridioides difficile Infection (CDI) That Are Associated With Increased Risk of Multiple CDI Recurrences
Guh A, Li R, Korhonen L, Winston L, Parker E, Czaja C, Johnston H, Basiliere E, Meek J, Olson D, Fridkin S, Wilson L, Perlmutter R, Holzbauer S, D’Heilly P, Phipps E, Flores K, Dumyati G, Pierce R, Ocampo V, Wilson C, Watkins J, Gerding D, McDonald L. Characteristics of Patients With Initial Clostridioides difficile Infection (CDI) That Are Associated With Increased Risk of Multiple CDI Recurrences. Open Forum Infectious Diseases 2024, 11: ofae127. PMID: 38577028, PMCID: PMC10993058, DOI: 10.1093/ofid/ofae127.Peer-Reviewed Original ResearchRecurrent Clostridioides difficile infectionClostridioides difficile infectionInitial CDINitrofurantoin useMultiple recurrent Clostridioides difficile infectionsPositive testPositive C. difficile testMultiple CDI recurrencesMultivariate logistic regression analysisPrevent further recurrenceAssociated with increased riskIntervention study designProportion of patientsTime of presentationCharacteristics of patientsLogistic regression analysisClinical decision makingCDI recurrenceChronic hemodialysisAdjunctive therapyIncreased riskMultivariate analysisStudy designPatientsClinical settingRetrospective 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 interestTEAEsEfficacy 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 infection
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 rate684. Characteristics of Patients with Initial Clostridioides difficile Infection (CDI) That Are Associated With Increased Risk of Multiple CDI Recurrences
Guh A, Li R, Korhonen L, Winston L, Parker E, Czaja C, Johnston H, Basiliere E, Meek J, Olson D, Fridkin S, Wilson L, Perlmutter R, Holzbauer S, D’Heilly P, Phipps E, Flores K, Dumyati G, Pierce R, Ocampo V, Wilson C, Watkins J, Gerding D, McDonald L. 684. Characteristics of Patients with Initial Clostridioides difficile Infection (CDI) That Are Associated With Increased Risk of Multiple CDI Recurrences. Open Forum Infectious Diseases 2023, 10: ofad500.746. PMCID: PMC10677783, DOI: 10.1093/ofid/ofad500.746.Peer-Reviewed Original ResearchEmerging Infections ProgramClostridioides difficile infectionInitial Clostridioides difficile infectionInitial CDICharacteristics of patientsRecurrent CDIPositive testNitrofurantoin useRecent hospitalizationDifficile infectionPrevention's Emerging Infections ProgramRecurrent Clostridioides difficile infectionMultivariable logistic regression modelMultiple recurrent CDIPrevious positive testTime of presentationFull chart reviewGrant/research supportPrior positive testLogistic regression modelsRace/ethnicityChronic hemodialysisAdjunctive therapyChart reviewConclusions Patients366. 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 microbiomeRCDITrends in and Risk Factors for Recurrent Clostridioides difficile Infection, New Haven County, Connecticut, USA, 2015–2020 - Volume 29, Number 5—May 2023 - Emerging Infectious Diseases journal - CDC
Okafor C, Clogher P, Olson D, Niccolai L, Hadler J. Trends in and Risk Factors for Recurrent Clostridioides difficile Infection, New Haven County, Connecticut, USA, 2015–2020 - Volume 29, Number 5—May 2023 - Emerging Infectious Diseases journal - CDC. Emerging Infectious Diseases 2023, 29: 877-887. PMID: 37081745, PMCID: PMC10124664, DOI: 10.3201/eid2905.221294.Peer-Reviewed Original ResearchConceptsRecurrent Clostridioides difficile infectionClostridioides difficile infectionNew Haven CountyPopulation-based laboratory surveillanceRisk factorsMedical risk factorsC. difficile casesHospital-onset casesNitrofurantoin useLaboratory surveillanceHealthcare systemIncreasing burdenTime trendsAssociated variablesIdentified factorsInfectionCOVID-19 pandemicMultiple regressionIncidenceCDCCountyConnecticutMalignancy
2020
Long-term Outcomes Following Multiply Recurrent Clostridioides difficile Infection and Fecal Microbiota Transplantation
Dawwas GK, Brensinger CM, Vajravelu RK, Wu Q, Kelly CR, Laine L, Wu GD, Lewis JD. Long-term Outcomes Following Multiply Recurrent Clostridioides difficile Infection and Fecal Microbiota Transplantation. Clinical Gastroenterology And Hepatology 2020, 20: 806-816.e6. PMID: 33307184, PMCID: PMC8184854, DOI: 10.1016/j.cgh.2020.12.004.Peer-Reviewed Original ResearchConceptsFecal microbiota transplantationIrritable bowel syndromeImmune-mediated diseasesBowel syndromeMyocardial infarctionMicrobiota transplantationRecurrent Clostridioides difficile infectionRecurrent Clostridioides difficileRetrospective cohort studyImmune-mediated conditionsInflammatory bowel diseaseInflammatory bowel syndromeCommercial claims databaseLong-term outcomesClostridioides difficile infectionCohort studyBowel diseaseMicrobiota disturbanceRheumatoid arthritisClaims databaseDifficile infectionHigh riskHigh incidenceGut microbiotaSignificant association
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