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 eventsPlaceboThe 3 Ds: Depression, Dysbiosis, and Clostridiodes difficile
Boustany A, Feuerstadt P, Tillotson G. The 3 Ds: Depression, Dysbiosis, and Clostridiodes difficile. Advances In Therapy 2024, 41: 3982-3995. PMID: 39276186, PMCID: PMC11480130, DOI: 10.1007/s12325-024-02972-0.Peer-Reviewed Original ResearchIncreased risk of C. difficile infectionRisk of C. difficile infectionClasses of antidepressantsClostridioides difficile infectionNovel treatment optionsPatients' quality of lifeMicrobiome-related factorsDevelopment of dysbiosisOpportunistic infectionsRecurrent CDIGut microbiomeRecurrence rateAntidepressant useDifficile infectionMental disordersTreatment optionsLive biotherapeutic productsComplex pathophysiologyIncreased riskC. difficileGut dysbiosisQuality of lifePatients' qualitySignificant healthcare concernAntidepressantsPUNCH 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 conditionsIntegrated 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 comorbiditiesRCDIWeeksAntibioticsPatientsComorbiditiesEfficacyPlaceboMicrobiomeCorrection 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 ResearchSa1898 RACIAL DISPARITIES IN PATIENTS HOSPITALIZED WITH CLOSTRIDIOIDES DIFFICILE INFECTION: A POPULATION-BASED STUDY
Chaar A, Rizwan R, Patel S, Sehgal K, Richter T, Nawaz A, Feuerstadt P. Sa1898 RACIAL DISPARITIES IN PATIENTS HOSPITALIZED WITH CLOSTRIDIOIDES DIFFICILE INFECTION: A POPULATION-BASED STUDY. Gastroenterology 2024, 166: s-569-s-570. DOI: 10.1016/s0016-5085(24)01783-9.Peer-Reviewed Original ResearchFrailty is a predictor for worse outcomes in patients hospitalized with Clostridioides difficile infection
Chaar A, Yoo J, Nawaz A, Rizwan R, Agha O, Feuerstadt P. Frailty is a predictor for worse outcomes in patients hospitalized with Clostridioides difficile infection. Annals Of Gastroenterology 2024, 37: 442-448. PMID: 38974087, PMCID: PMC11226747, DOI: 10.20524/aog.2024.0898.Peer-Reviewed Original ResearchHospital Frailty Risk ScoreHealthcare resource utilizationHigher healthcare utilizationAdministrative billing dataPrimary diagnosis of CDIFrailty Risk ScoreNational Inpatient SampleHigher healthcare resource utilizationIntensive care unit admissionHealthcare utilizationClostridioides difficile</i> infectionFrailty statusDiagnosis of CDIRisk-stratify patientsHigher oddsClostridioides difficile infectionInpatient mortalityPerioperative risk assessmentHospital outcomesBilling dataRisk scoreInpatient SampleFrailtyAssessed differencesHealth implicationsEfficacy 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 ResearchRetrospective 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
2019
197 Annual Hospitalization and Mortality Trends Among Patients With Sickle Cell Disease and Clostridioides difficile Infection
Sharma P, Hundt M, Aguilar R, Nader M, Yadav S, Rawlings R, Feuerstadt P. 197 Annual Hospitalization and Mortality Trends Among Patients With Sickle Cell Disease and Clostridioides difficile Infection. The American Journal Of Gastroenterology 2019, 114: s120-s121. DOI: 10.14309/01.ajg.0000590320.20381.01.Peer-Reviewed Original ResearchClostridioides difficile infectionSickle cell diseaseInpatient mortalityIncidence of Clostridioides difficile infectionCell diseaseSickle cell disease related complicationsAggressive initial treatmentAssociated with atrial fibrillationSickle cell disease patientsAcute chest syndromeAssociated with HIVNational Inpatient Sample databaseVaso-occlusive crisisChronic liver diseaseInpatient Sample databasePropensity score matchingChest syndromeComplication rateChronic pancreatitisHepatitis CInitial treatmentPaired t-testRelated complicationsAcute pancreatitisAntibiotic exposure