2024
Endoscopic diagnosis and management of adult inflammatory bowel disease: a consensus document from the American Society for Gastrointestinal Endoscopy IBD Endoscopy Consensus Panel
Panel T, Shen B, Abreu M, Cohen E, Farraye F, Fischer M, Feuerstadt P, Kapur S, Ko H, Kochhar G, Liu X, Mahadevan U, McBride D, Navaneethan U, Regueiro M, Ritter T, Sharma P, Lichtenstein G. Endoscopic diagnosis and management of adult inflammatory bowel disease: a consensus document from the American Society for Gastrointestinal Endoscopy IBD Endoscopy Consensus Panel. Gastrointestinal Endoscopy 2024 PMID: 39425706, DOI: 10.1016/j.gie.2024.08.034.Peer-Reviewed Original ResearchInflammatory bowel diseaseInflammatory bowel disease specialistsAssessment of treatment responseBowel diseaseClinical practice patternsConsensus documentMonitoring of disease activityAdult inflammatory bowel diseaseDysplasia surveillancePractice patternsGI pathologistsEndoscopic aspectDisease activityEndoscopic managementPostoperative evaluationConsensus panelTreatment responseInterventional therapyEndoscopic diagnosisIBD managementDiagnosisDiseaseSafety 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 eventsPlaceboS733 Efficacy, Safety and Time to Response of Linaclotide in Adult Patients With Chronic Idiopathic Constipation: A Post Hoc Subgroup Analysis by Age
Chang L, Brenner D, Chen W, Yerneni N, Wu J, Feuerstadt P, Staller K. S733 Efficacy, Safety and Time to Response of Linaclotide in Adult Patients With Chronic Idiopathic Constipation: A Post Hoc Subgroup Analysis by Age. The American Journal Of Gastroenterology 2024, 119: s503-s504. DOI: 10.14309/01.ajg.0001032300.07115.42.Peer-Reviewed Original ResearchS770 Efficacy and Safety of Linaclotide in Patients With Chronic Idiopathic Constipation: A Post Hoc Analysis of Phase 3 Clinical Study Data Assessing Primary and Additional Endpoints by Race and Ethnicity, and by Age
Moshiree B, Chang L, Boules M, Chen W, Wu J, Li M, Feuerstadt P, Staller K. S770 Efficacy and Safety of Linaclotide in Patients With Chronic Idiopathic Constipation: A Post Hoc Analysis of Phase 3 Clinical Study Data Assessing Primary and Additional Endpoints by Race and Ethnicity, and by Age. The American Journal Of Gastroenterology 2024, 119: s530-s531. DOI: 10.14309/01.ajg.0001032448.76293.ca.Peer-Reviewed Original ResearchA real-world study of persistence and adherence to prescription medications in patients with chronic idiopathic constipation in the United States.
Cash B, Lu M, Lembo A, Feuerstadt P, Nguyen L, Terasawa E, Ayyagari R, Du S, Pi S, Westermeyer B, Terreri B, Boules M, Moshiree B. A real-world study of persistence and adherence to prescription medications in patients with chronic idiopathic constipation in the United States. Journal Of Managed Care & Specialty Pharmacy 2024, 30: 1136-1148. PMID: 39321115, PMCID: PMC11424913, DOI: 10.18553/jmcp.2024.30.10.1136.Peer-Reviewed Original ResearchConceptsChronic idiopathic constipationHazard ratioIdiopathic constipationTreatment of chronic idiopathic constipationHigher treatment persistencePrescription medicationsComparator medicationUS Food and Drug AdministrationProportion of patientsIBM MarketScan Commercial ClaimsObservational cohort studyFood and Drug AdministrationAdjusted hazard ratiosMarketScan Commercial ClaimsProportion of daysAssociated with lower oddsTreatment persistencePrucaloprideCohort studyOdds ratioPrescription fillsPrescription therapyDrug AdministrationCompare persistenceInclusion criteriaThe 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 concernAntidepressantsCorrection to: 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. Correction to: Integrated Safety and Efficacy Analyses of Phase 3 Trials of a Microbiome Therapeutic for Recurrent CDI. Infectious Diseases And Therapy 2024, 13: 2209-2210. PMID: 39212853, PMCID: PMC11416435, DOI: 10.1007/s40121-024-01036-8.Peer-Reviewed Original ResearchPUNCH 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 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, 167: 885-902. 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 diseasesSequenceCorrection 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 ResearchSa1901 EFFICACY AND SAFETY OF FECAL MICROBIOTA, LIVE-JSLM IN PARTICIPANTS WITH RECURRENT CLOSTRIDIOIDES DIFFICILE INFECTION RECEIVING CONCOMITANT MEDICATIONS
Tillotson G, Feuerstadt P, Carlson T, Guthmueller B, Martinez A, Reveles K. Sa1901 EFFICACY AND SAFETY OF FECAL MICROBIOTA, LIVE-JSLM IN PARTICIPANTS WITH RECURRENT CLOSTRIDIOIDES DIFFICILE INFECTION RECEIVING CONCOMITANT MEDICATIONS. Gastroenterology 2024, 166: s-571. DOI: 10.1016/s0016-5085(24)01786-4.Peer-Reviewed Original ResearchTu1653 EFFICACY, SAFETY, AND TIME TO RESPONSE OF LINACLOTIDE IN PATIENTS ≥65 WITH IRRITABLE BOWEL SYNDROME WITH CONSTIPATION
Chang L, Brenner D, Chen W, Yerneni N, Wu J, Feuerstadt P, Staller K. Tu1653 EFFICACY, SAFETY, AND TIME TO RESPONSE OF LINACLOTIDE IN PATIENTS ≥65 WITH IRRITABLE BOWEL SYNDROME WITH CONSTIPATION. Gastroenterology 2024, 166: s-1366. DOI: 10.1016/s0016-5085(24)03590-x.Peer-Reviewed Original ResearchMo1345 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 treatmentPatientsFrailty 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