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
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, 31: 2112-2122. PMID: 39862395, PMCID: PMC12342783, 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 success
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