2024
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
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 treatmentPatientsRetrospective 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