2024
A randomized controlled trial of efficacy and safety of Fecal Microbiota Transplant for preventing recurrent Clostridioides difficile infection
Drekonja D, Shaukat A, Huang Y, Zhang J, Reinink A, Nugent S, Dominitz J, Davis-Karim A, Gerding D, Kyriakides T. A randomized controlled trial of efficacy and safety of Fecal Microbiota Transplant for preventing recurrent Clostridioides difficile infection. Clinical Infectious Diseases 2024, ciae467. PMID: 39271107, DOI: 10.1093/cid/ciae467.Peer-Reviewed Original ResearchCDI recurrenceClostridioides difficile infectionFecal microbiota transplantationRecurrent Clostridioides difficile infectionAdverse eventsPreventing recurrent Clostridioides difficile infectionOral fecal microbiota transplantationMicrobiota transplantationCause of healthcare-associated infectionsSafety of fecal microbiota transplantationDouble-blind clinical trialTrials of efficacyHealthcare-associated infectionsStatistically significant differenceRandomized controlled trialsClinical recurrenceUnformed stoolsPlacebo armPlacebo capsulesPrimary endpointDifficile infectionRecurrent diarrheaAntibiotic treatmentVeterans Health Administration systemClinical trials
2021
Microbiota or placebo after antimicrobial therapy for recurrent Clostridioides difficile at home: A clinical trial with novel home-based enrollment
Drekonja DM, Shaukat A, Zhang JH, Reinink AR, Nugent S, Dominitz JA, Davis-Karim A, Gerding DN, Kyriakides TC. Microbiota or placebo after antimicrobial therapy for recurrent Clostridioides difficile at home: A clinical trial with novel home-based enrollment. Clinical Trials 2021, 18: 622-629. PMID: 34154439, DOI: 10.1177/17407745211021198.Peer-Reviewed Original ResearchConceptsClinical trialsCase identificationRecurrent infectionsIndividuals meeting inclusion criteriaVeterans Affairs Corporate Data WarehouseFrequent antimicrobial usePrevention of recurrentRecurrent Clostridioides difficileSuccessful initial treatmentFecal microbiota transplantationIncidence of recurrentVeterans Affairs systemFecal microbiota transplantNationwide clinical trialMeeting inclusion criteriaQuality of lifeCorporate Data WarehouseTransplant administrationPrimary endpointStandard therapySubstantial morbidityInitial treatmentCapsule administrationMicrobiota transplantationRandomized comparison