2025
Safety and effectiveness of fecal microbiota, live-jslm (REBYOTA®) administered by colonoscopy for prevention of recurrent Clostridioides difficile infection: 8-week results from CDI-SCOPE, a single-arm, phase IIIb trial
Khanna S, Yoho D, Van Handel D, Clark B, Awad T, Guthmueller B, Armandi D, Knapple W, Safdar N, Baggott B, Simon K, Feuerstadt P. Safety and effectiveness of fecal microbiota, live-jslm (REBYOTA®) administered by colonoscopy for prevention of recurrent Clostridioides difficile infection: 8-week results from CDI-SCOPE, a single-arm, phase IIIb trial. Therapeutic Advances In Gastroenterology 2025, 18: 17562848251339697. PMID: 40321366, PMCID: PMC12049624, DOI: 10.1177/17562848251339697.Peer-Reviewed Original ResearchTreatment-emergent adverse eventsPhase IIIb trialAntibiotic treatmentPrevention of recurrent CDINo treatment emergent adverse eventsTreatment successRecurrent Clostridioides difficile infectionClostridioides difficile</i> infectionIntensive care unit admissionParticipation benefitsPrevent CDI recurrenceClostridioides difficile infectionRoute of administrationPhysicians' perceptionsPreventing rCDICDI recurrenceTreatment failureEligible adultsSecondary endpointsFecal microbiotaEffects of fecal microbiotaUnit admissionDifficile infectionAdverse eventsPhysician experienceSafety and Efficacy of Fecal Microbiota, Live-jslm (REBYOTA®), for the Prevention of Recurrent Clostridioides difficile Infection in Participants With Inflammatory Bowel Disease in PUNCH CD3-OLS
Allegretti J, Feuerstadt P, Knapple W, Orenstein R, Pinton P, Sheh A, Khanna S. Safety and Efficacy of Fecal Microbiota, Live-jslm (REBYOTA®), for the Prevention of Recurrent Clostridioides difficile Infection in Participants With Inflammatory Bowel Disease in PUNCH CD3-OLS. Inflammatory Bowel Diseases 2025, izae291. PMID: 39862395, DOI: 10.1093/ibd/izae291.Peer-Reviewed Original ResearchTreatment-emergent adverse eventsRecurrent Clostridioides difficile infectionInflammatory bowel diseaseClostridioides difficile infectionWeeks of administrationPrevention of recurrent CDISerious treatment-emergent adverse eventsSubgroup analysisSustained clinical response ratesBowel diseaseSustained clinical responseClinical response rateModerate gastrointestinal symptomsUS Food and Drug AdministrationTreatment success rateFood and Drug AdministrationClinical responseSingle-doseProspective trialsFecal microbiotaEfficacy outcomesDifficile infectionAdverse eventsGastrointestinal symptomsTreatment successAlterations in Gut Microbiome-Host Relationships After Immune Perturbation in Patients With Multiple Sclerosis
Gupta V, Janda G, Pump H, Lele N, Cruz I, Cohen I, Ruff W, Hafler D, Sung J, Longbrake E. Alterations in Gut Microbiome-Host Relationships After Immune Perturbation in Patients With Multiple Sclerosis. Neurology Neuroimmunology & Neuroinflammation 2025, 12: e200355. PMID: 39819054, PMCID: PMC11741292, DOI: 10.1212/nxi.0000000000200355.Peer-Reviewed Original ResearchConceptsAmplicon sequence variantsIgA-coatedGut microbiomeBacterial fractionRRNA gene amplicon sequencingLong-read sequencingGut microbial symbiontsGene amplicon sequencingMultiple sclerosisStool samplesProportion of bacteriaB cellsHost-microbial interfaceAnti-CD20 monoclonal antibody treatmentDiagnosing MSMicrobial symbiontsIgA-secreting B cellsTaxonomic resolutionSequence variantsAmplicon sequencingB-cell depletionFecal microbiotaMonths of treatmentMonoclonal antibody treatmentDevelopment of autoimmunity
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
2021
Congenital iRHOM2 deficiency causes ADAM17 dysfunction and environmentally directed immunodysregulatory disease
Kubo S, Fritz J, Raquer-McKay H, Kataria R, Vujkovic-Cvijin I, Al-Shaibi A, Yao Y, Zheng L, Zou J, Waldman A, Jing X, Farley T, Park A, Oler A, Charles A, Makhlouf M, AbouMoussa E, Hasnah R, Saraiva L, Ganesan S, Al-Subaiey A, Matthews H, Flano E, Lee H, Freeman A, Sefer A, Sayar E, Çakır E, Karakoc-Aydiner E, Baris S, Belkaid Y, Ozen A, Lo B, Lenardo M. Congenital iRHOM2 deficiency causes ADAM17 dysfunction and environmentally directed immunodysregulatory disease. Nature Immunology 2021, 23: 75-85. PMID: 34937930, PMCID: PMC11060421, DOI: 10.1038/s41590-021-01093-y.Peer-Reviewed Original ResearchMeSH KeywordsA549 CellsADAM17 ProteinAnimalsCarrier ProteinsChildChild, PreschoolCitrobacter rodentiumColitisCytokinesEnterobacteriaceae InfectionsFemaleHEK293 CellsHumansInfant, NewbornMacrophagesMaleMiceMice, Inbred C57BLMutationPrimary Immunodeficiency DiseasesPseudomonas aeruginosaPseudomonas InfectionsSignal TransductionConceptsIRhom2 deficiencyLoss-of-function mutationsLocal microbial environmentLoss of iRhom2Diverse clinical phenotypesRecurrent respiratory infectionsWild-type miceRelease of cytokinesTumor necrosis factorHemorrhagic colitisCitrobacter rodentiumADAM17 metalloproteinaseFecal microbiotaSuperfamily membersRecurrent infectionsRecurrent pneumoniaTumor necrosisLung involvementColonic involvementHuman immunodeficiencyInflammatory colitisMicrobial environmentOral speciesPseudomonas aeruginosaColitis patientsThe Mucosally-Adherent Rectal Microbiota Contains Features Unique to Alcohol-Related Cirrhosis
Shen TD, Daniel SG, Patel S, Kaplan E, Phung L, Lemelle-Thomas K, Chau L, Herman L, Trisolini C, Stonelake A, Toal E, Khungar V, Bittinger K, Reddy KR, Wu GD. The Mucosally-Adherent Rectal Microbiota Contains Features Unique to Alcohol-Related Cirrhosis. Gut Microbes 2021, 13: 1987781. PMID: 34747331, PMCID: PMC8583005, DOI: 10.1080/19490976.2021.1987781.Peer-Reviewed Original ResearchConceptsAlcohol-related cirrhosisRectal swabsBacterial culture studiesAssociated gut microbiomeCross-sectional analysisHost-derived metabolitesConcentration-dependent mannerAdult patientsMucosal microenvironmentCirrhosis etiologyPatient populationDifferent etiologiesColonic mucosaCirrhosisMucosal microbiotaGut microbiotaGut microbiomeAdherent microbiotaFecal microbiotaOxidative metabolitesSwabsStoolDisease statesEase of collectionCellular proliferation
2020
A prebiotic-enhanced lipid-based nutrient supplement (LNSp) increases Bifidobacterium relative abundance and enhances short-chain fatty acid production in simulated colonic microbiota from undernourished infants
Toe L, Kerckhof F, De Bodt J, Morel F, Ouedraogo J, Kolsteren P, Van de Wiele T. A prebiotic-enhanced lipid-based nutrient supplement (LNSp) increases Bifidobacterium relative abundance and enhances short-chain fatty acid production in simulated colonic microbiota from undernourished infants. FEMS Microbiology Ecology 2020, 96: fiaa105. PMID: 32568403, DOI: 10.1093/femsec/fiaa105.Peer-Reviewed Original ResearchConceptsLipid-based nutrient supplementsBifidobacterium relative abundanceFatty acid productionAcid productionBranched-chain fatty acid productionNew therapeutic pathsLower gut microbiota diversityGut microbiota compositionPublic health problemHuman Intestinal Microbial EcosystemGut microbiota diversityIntestinal microbial ecosystemShort-chain fatty acid productionNutrient supplementsUndernourished infantsUndernourished childrenDynamic gut modelDeath proportionsMicrobiota compositionColonic microbiotaHealth problemsNutritional statusTherapeutic pathFecal microbiotaMicrobiota diversity
2018
Differences in the fecal microbiota of neonates born at home or in the hospital
Combellick JL, Shin H, Shin D, Cai Y, Hagan H, Lacher C, Lin DL, McCauley K, Lynch SV, Dominguez-Bello MG. Differences in the fecal microbiota of neonates born at home or in the hospital. Scientific Reports 2018, 8: 15660. PMID: 30353125, PMCID: PMC6199260, DOI: 10.1038/s41598-018-33995-7.Peer-Reviewed Original ResearchConceptsHospital-born infantsTime of birthPro-inflammatory gene expressionBreast fed neonatesInfants 1 monthLong-term health implicationsHuman colon epithelial HT-29 cellsDay of birthVaginal swab samplesMonths of ageLower BacteroidesMaternal antibioticsNeonate's microbiomeNeonatal microbiomeVaginal sourcesHT-29 cellsWater birthVaginal microbiotaIntestinal microbiotaDay 1Vaginal samplesHospitalInfantsFecal microbiotaBabies
2016
Gut microbiota community adaption during young children fecal microbiota transplantation by 16s rDNA sequencing
Gu J, Wang Y, Liu S, Yu G, Zhang T, Lu H. Gut microbiota community adaption during young children fecal microbiota transplantation by 16s rDNA sequencing. Neurocomputing 2016, 206: 66-72. DOI: 10.1016/j.neucom.2016.01.095.Peer-Reviewed Original ResearchFecal microbiota transplantationMicrobiota transplantationGastrointestinal disordersGastrointestinal diseasesChronic gastrointestinal diseasePediatric gastrointestinal disordersFecal microbiota compositionUseful treatment methodRDNA sequencing technologyAdult patientsFMT treatmentYounger patientsFecal transplantationHealthy donorsIntestinal microbiotaMicrobiota compositionPatientsTransplantationInterindividual variabilityFecal microbiotaIntestinal environmentYoung childrenDiseased individualsDiseaseTreatment methodsIndividual-specific changes in the human gut microbiota after challenge with enterotoxigenic Escherichia coli and subsequent ciprofloxacin treatment
Pop M, Paulson J, Chakraborty S, Astrovskaya I, Lindsay B, Li S, Bravo H, Harro C, Parkhill J, Walker A, Walker R, Sack D, Stine O. Individual-specific changes in the human gut microbiota after challenge with enterotoxigenic Escherichia coli and subsequent ciprofloxacin treatment. BMC Genomics 2016, 17: 440. PMID: 27277524, PMCID: PMC4898365, DOI: 10.1186/s12864-016-2777-0.Peer-Reviewed Original ResearchConceptsGene sequencesBackgroundEnterotoxigenic Escherichia coliHuman gut microbiotaRRNA gene sequencesEnterotoxigenic Escherichia coliHuman intestinal microbiotaFecal E. coliCiprofloxacin treatmentETEC infectionETEC diarrheaRibosomal RNAGut microbiotaFecal microbiotaIntestinal microbiotaE. coliMicrobiotaMonthly follow-up visitsCompared to variationsETECFollow-up visitQuantitative PCRHuman challenge studiesCiprofloxacinQuantitative culturesSequence
2011
NLRP6 Inflammasome Regulates Colonic Microbial Ecology and Risk for Colitis
Elinav E, Strowig T, Kau AL, Henao-Mejia J, Thaiss CA, Booth CJ, Peaper DR, Bertin J, Eisenbarth SC, Gordon JI, Flavell RA. NLRP6 Inflammasome Regulates Colonic Microbial Ecology and Risk for Colitis. Cell 2011, 145: 745-757. PMID: 21565393, PMCID: PMC3140910, DOI: 10.1016/j.cell.2011.04.022.Peer-Reviewed Original ResearchConceptsDextran sodium sulfateDamage-associated molecular patternsIL-18 levelsInflammatory cell recruitmentInflammasome-deficient miceWild-type miceColonic microbial ecologyMouse colonic epithelial cellsColonic epithelial cellsColitogenic activityDSS colitisHuman IBDChemical colitisIL-18Antibiotic treatmentInflammasome pathwayNLRP6 inflammasomeCell recruitmentIntestinal hyperplasiaColitisCaspase-1Fecal microbiotaMolecular patternsEpithelial cellsExacerbation
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