Alanyl-glutamine Supplementation for Clostridioides difficile Infection Treatment (ACT): A double-blind randomized controlled trial

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dc.contributor.authorWarren, Cirle A.en
dc.contributor.authorShin, Jae Hyunen
dc.contributor.authorBansal, Ekta N.en
dc.contributor.authorCosta, Deiziane V. D. S.en
dc.contributor.authorWang, Xin Qunen
dc.contributor.authorWu, Martinen
dc.contributor.authorSwann, Jonathan R.en
dc.contributor.authorBehm, Brian W.en
dc.contributor.authorTargonski, Paul V.en
dc.contributor.authorArchbald-Pannone, Laurieen
dc.date.accessioned2024-06-10T14:38:17Zen
dc.date.available2024-06-10T14:38:17Zen
dc.date.issued2023-07-19en
dc.description.abstractIntroduction: Clostridioides difficile is the leading cause of healthcare-associated infections in the USA, with an estimated 1 billion dollars in excess cost to the healthcare system annually. C. difficile infection (CDI) has high recurrence rate, up to 25% after first episode and up to 60% for succeeding episodes. Preliminary in vitro and in vivo studies indicate that alanyl-glutamine (AQ) may be beneficial in treating CDI by its effect on restoring intestinal integrity in the epithelial barrier, ameliorating inflammation and decreasing relapse. Methods and analysis: This study is a randomised, placebo-controlled, double-blind, phase II clinical trial. The trial is designed to determine optimal dose and safety of oral AQ at 4, 24 and 44 g doses administered daily for 10 days concurrent with standard treatment of non-severe or severe uncomplicated CDI in persons age 18 and older. The primary outcome of interest is CDI recurrence during 60 days post-treatment follow-up, with the secondary outcome of mortality during 60 days post-treatment follow-up. Exploratory analysis will be done to determine the impact of AQ supplementation on intestinal and systemic inflammation, as well as intestinal microbial and metabolic profiles. Ethics and dissemination: The study has received University of Virginia Institutional Review Board approval (HSR200046, Protocol v9, April 2023). Findings will be disseminated via conference presentations, lectures and peer-reviewed publications. Trial registration number NCT04305769.en
dc.description.versionPublished versionen
dc.format.extent7 page(s)en
dc.format.mimetypeapplication/pdfen
dc.identifierARTN e075721 (Article number)en
dc.identifier.doihttps://doi.org/10.1136/bmjopen-2023-075721en
dc.identifier.eissn2044-6055en
dc.identifier.issn2044-6055en
dc.identifier.issue7en
dc.identifier.orcidBansal, Ekta [0000-0003-1989-9493]en
dc.identifier.otherbmjopen-2023-075721 (PII)en
dc.identifier.pmid37474181en
dc.identifier.urihttps://hdl.handle.net/10919/119373en
dc.identifier.volume13en
dc.language.isoenen
dc.publisherBMJ Journalsen
dc.relation.urihttps://www.ncbi.nlm.nih.gov/pubmed/37474181en
dc.rightsCreative Commons Attribution-NonCommercial 4.0 Internationalen
dc.rights.urihttp://creativecommons.org/licenses/by-nc/4.0/en
dc.subjectgastrointestinal infectionsen
dc.subjectinfectious diseasesen
dc.subjectgastroenterologyen
dc.subjectrandomized controlled trialen
dc.subjectclinical trialsen
dc.subject.meshHumansen
dc.subject.meshClostridium Infectionsen
dc.subject.meshNeoplasm Recurrence, Localen
dc.subject.meshInflammationen
dc.subject.meshTreatment Outcomeen
dc.subject.meshDouble-Blind Methoden
dc.subject.meshDietary Supplementsen
dc.subject.meshAdolescenten
dc.subject.meshAdulten
dc.subject.meshRandomized Controlled Trials as Topicen
dc.subject.meshClinical Trials, Phase II as Topicen
dc.subject.meshClostridioides difficileen
dc.titleAlanyl-glutamine Supplementation for <i>Clostridioides difficile</i> Infection Treatment (ACT): A double-blind randomized controlled trialen
dc.title.serialBMJ Openen
dc.typeArticle - Refereeden
dc.type.dcmitypeTexten
dc.type.otherArticleen
dcterms.dateAccepted2023-06-21en
pubs.organisational-group/Virginia Techen
pubs.organisational-group/Virginia Tech/VT Carilion School of Medicineen
pubs.organisational-group/Virginia Tech/VT Carilion School of Medicine/Internal Medicineen
pubs.organisational-group/Virginia Tech/VT Carilion School of Medicine/Internal Medicine/Infectious Diseaseen

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