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 concernAntidepressantsLive biotherapeutic products: a capstone for prevention of recurrent Clostridiodes difficile infection
Sehgal K, Feuerstadt P. Live biotherapeutic products: a capstone for prevention of recurrent Clostridiodes difficile infection. Frontiers In Microbiomes 2024, 3: 1399440. DOI: 10.3389/frmbi.2024.1399440.Peer-Reviewed Original ResearchClostridiodes difficile infectionLive biotherapeutic productsFecal microbiota transplantationStandard of careDifficile infectionFDA approvalHealthcare-acquired diarrheaReduction of recurrenceReducing CDI recurrencePrevention of recurrenceGut microbiotaGastrointestinal microbiotaCDI recurrenceAntimicrobial therapyMicrobiotaInfection onsetMicrobiota transplantationRecurrenceClinical practiceInfectionBiotherapeutic productsTherapyFDADeficiencyPreventionCorrection 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 ResearchEfficacy and Health-Related Quality of Life Impact of Fecal Microbiota, Live-jslm: A Post Hoc Analysis of PUNCH CD3 Patients at First Recurrence of Clostridioides difficile Infection
Feuerstadt P, Allegretti J, Dubberke E, Guo A, Harvey A, Yang M, Garcia-Horton V, Fillbrunn M, Tillotson G, Bancke L, LaPlante K, Garey K, Khanna S. Efficacy and Health-Related Quality of Life Impact of Fecal Microbiota, Live-jslm: A Post Hoc Analysis of PUNCH CD3 Patients at First Recurrence of Clostridioides difficile Infection. Infectious Diseases And Therapy 2024, 13: 221-236. PMID: 38236515, PMCID: PMC10828144, DOI: 10.1007/s40121-023-00907-w.Peer-Reviewed Original ResearchRecurrence of CDIHealth-related quality of lifeTreatment successPost hoc analysisAntibiotic treatmentDouble-blind placebo-controlled clinical trialPlacebo-controlled clinical trialBlinded phaseHealth-related qualityProbability of treatment successBaseline to weekOdds of recurrenceBaseline patient characteristicsHealth-related quality of life impactCD3- patientsFecal microbiotaAnalyzed efficacyDifficile infectionEligible patientsPatient characteristicsClinical trialsPlaceboRecurrenceEffective treatmentPatientsEfficacy 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