Alanyl-glutamine supplementation for Clostridioides difficile infection treatment (ACT): a double-blind randomised controlled trial study protocol.

Autor:	Warren CA; Department of Medicine, Division of Infectious Diseases and International Health, University of Virginia School of Medicine, Charlottesville, Virginia, USA ca6t@virginia.edu., Shin JH; Department of Medicine, Division of Infectious Diseases and International Health, University of Virginia School of Medicine, Charlottesville, Virginia, USA., Bansal EN; Department of Internal Medicine, Virginia Tech Carilion School of Medicine, Roanoke, Virginia, USA., Costa DVDS; Department of Medicine, Division of Infectious Diseases and International Health, University of Virginia School of Medicine, Charlottesville, Virginia, USA., Wang XQ; Department of Public Health Sciences, University of Virginia School of Medicine, Charlottesville, VA, USA., Wu M; Department of Biology, University of Virginia College and Graduate School of Arts and Sciences, Charlottesville, VA, USA., Swann JR; School of Human Development and Health, University of Southampton Faculty of Medicine, Southampton, UK., Behm BW; Department of Medicine, Division of Gastroenterology and Hepatology, University of Virginia School of Medicine, Charlottesville, VA, USA., Targonski PV; Department of Public Health Sciences, University of Virginia School of Medicine, Charlottesville, VA, USA.; Department of Medicine, Division of General, Geriatric, Palliative & Hospital Medicine, University of Virginia School of Medicine, Charlottesville, VA, USA., Archbald-Pannone L; Department of Medicine, Division of General, Geriatric, Palliative & Hospital Medicine, University of Virginia School of Medicine, Charlottesville, VA, USA.
Jazyk:	angličtina
Zdroj:	BMJ open [BMJ Open] 2023 Jul 19; Vol. 13 (7), pp. e075721. Date of Electronic Publication: 2023 Jul 19.
DOI:	10.1136/bmjopen-2023-075721
Abstrakt:	Introduction: 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. Competing Interests: Competing interests: CW is a medical advisor for Seres-109 of Aimmune and Seres Therapeutics and site PI for Rebyota Prospective Registry. The rest of the authors have no conflict of interest to disclose. (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
Databáze:	MEDLINE
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