2024
Integrated 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, 1-17. PMID: 38941068, 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 comorbiditiesRCDIWeeksAntibioticsPatientsComorbiditiesEfficacyPlaceboMicrobiomeLive 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 productsTherapyFDADeficiencyPreventionThe Progression of Microbiome Therapeutics for the Management of Gastrointestinal Diseases and Beyond
Allegretti J, Khanna S, Mullish B, Feuerstadt P. The Progression of Microbiome Therapeutics for the Management of Gastrointestinal Diseases and Beyond. Gastroenterology 2024 PMID: 38754739, DOI: 10.1053/j.gastro.2024.05.004.Peer-Reviewed Original ResearchFecal microbiota transplantationMicrobiome therapeuticsNext generation sequencingIntestinal ecosystemHuman microbiotaMicrobiota restorationGeneration sequencingGastrointestinal microbiomeMicrobiota transplantationMicrobiotaExtraintestinal conditionsMitigate diseaseIncreased abilityEcosystemMicrobiomeTherapeuticsGastrointestinal diseasesSequenceMo1345 ACUTE VASCULAR INTESTINAL DISEASE IN PATIENTS WITH END-STAGE RENAL DISEASE: A NATIONAL ANALYSIS
Rizwan R, Chaar A, Sehgal K, Richter T, Nawaz A, Patel S, Feuerstadt P. Mo1345 ACUTE VASCULAR INTESTINAL DISEASE IN PATIENTS WITH END-STAGE RENAL DISEASE: A NATIONAL ANALYSIS. Gastroenterology 2024, 166: s-1033. DOI: 10.1016/s0016-5085(24)02849-x.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 ResearchSu1009 RACIAL DISPARITIES IN ACUTE VASCULAR INTESTINAL DISEASES: A NATIONAL ANALYSIS
Sehgal K, Chaar A, Rizwan R, Richter T, Feuerstadt P. Su1009 RACIAL DISPARITIES IN ACUTE VASCULAR INTESTINAL DISEASES: A NATIONAL ANALYSIS. Gastroenterology 2024, 166: s-634-s-635. DOI: 10.1016/s0016-5085(24)01916-4.Peer-Reviewed Original ResearchClinical Outcomes Before and After Prucalopride Treatment: An Observational Study in Patients With Chronic Idiopathic Constipation in the United States
Lembo A, Cash B, Lu M, Terasawa E, Terreri B, Du S, Ayyagari R, Feuerstadt P, Moshiree B, Westermeyer B, Pi S, Boules M. Clinical Outcomes Before and After Prucalopride Treatment: An Observational Study in Patients With Chronic Idiopathic Constipation in the United States. Clinical And Translational Gastroenterology 2024, 15: e00687. PMID: 38357940, PMCID: PMC11124638, DOI: 10.14309/ctg.0000000000000687.Peer-Reviewed Original ResearchConstipation-related symptomsChronic idiopathic constipationProportion of patientsComplications 6 monthsIdiopathic constipationRetrospective cohort analysisDecreased 6 monthsMedicare Supplemental databaseICD-10 procedurePatient ageTreatment initiationClinical outcomesPrucalopride treatmentCohort analysisComplicationsPrucaloprideObservational studyPatientsSupplemental databaseICD-10 Procedure Coding SystemCommercial ClaimsDiagnosis codesICD-10-CMSymptomsClinical ModificationEfficacy 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 treatmentPatientsErratum: Efficacy and Practical Implementation of Fecal Microbiota Spores, Live-BRPK: A Novel Approach for Preventing Recurrent Clostridioides difficile Infection.
Feuerstadt P, LaPlante K. Erratum: 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 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 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 interestTEAEsFrailty 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 implications
2023
Fecal Microbiota, Live-jslm for the Prevention of Recurrent Clostridioides difficile Infection : Subgroup Analysis of PUNCH CD2 and PUNCH CD3.
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 : Subgroup Analysis of PUNCH CD2 and PUNCH CD3. Journal Of Clinical Gastroenterology 2023 PMID: 38019088, 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 microbiomeRCDIThe real efficacy of microbiota restoration following standard of care antimicrobial in patients with recurrent Clostridiodes difficile
Sehgal K, Feuerstadt P. The real efficacy of microbiota restoration following standard of care antimicrobial in patients with recurrent Clostridiodes difficile. Translational Gastroenterology And Hepatology 2023, 8: 31-31. PMID: 38021361, PMCID: PMC10643224, DOI: 10.21037/tgh-23-46.Peer-Reviewed Original Research
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