Alanyl-glutamine supplementation for Clostridioides difficile infection treatment (ACT): a double-blind randomised controlled trial study protocol
Alanyl-glutamine supplementation for Clostridioides difficile infection treatment (ACT): a double-blind randomised controlled trial study protocol
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.
clinical trials, gastroenterology, gastrointestinal infections, infectious diseases, randomized controlled trial
Warren, Cirle A.
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Shin, Jae Hyun
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Bansal, Ekta N.
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Costa, Deiziane V.D.S.
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Wang, Xin Qun
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Wu, Martin
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Swann, Jonathan R.
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Behm, Brian W.
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Targonski, Paul V.
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Archbald-Pannone, Laurie
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19 July 2023
Warren, Cirle A.
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Shin, Jae Hyun
832f1d90-e510-4acb-a67b-0a7d41ffa53a
Bansal, Ekta N.
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Costa, Deiziane V.D.S.
6d63f10b-219a-4f02-90e2-66e341904c7e
Wang, Xin Qun
9c97f900-36e0-4874-bdeb-82d5e2775136
Wu, Martin
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Swann, Jonathan R.
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Behm, Brian W.
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Targonski, Paul V.
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Archbald-Pannone, Laurie
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Warren, Cirle A., Shin, Jae Hyun, Bansal, Ekta N., Costa, Deiziane V.D.S., Wang, Xin Qun, Wu, Martin, Swann, Jonathan R., Behm, Brian W., Targonski, Paul V. and Archbald-Pannone, Laurie
(2023)
Alanyl-glutamine supplementation for Clostridioides difficile infection treatment (ACT): a double-blind randomised controlled trial study protocol.
BMJ Open, 13 (7), [e075721].
(doi:10.1136/bmjopen-2023-075721).
Abstract
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.
Text
e075721.full
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Accepted/In Press date: 30 June 2023
Published date: 19 July 2023
Additional Information:
© 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.
Keywords:
clinical trials, gastroenterology, gastrointestinal infections, infectious diseases, randomized controlled trial
Identifiers
Local EPrints ID: 482463
URI: http://eprints.soton.ac.uk/id/eprint/482463
ISSN: 2044-6055
PURE UUID: bc3c8336-ee54-421e-8b11-0393b123dccc
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Date deposited: 05 Oct 2023 16:52
Last modified: 18 Mar 2024 03:56
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Contributors
Author:
Cirle A. Warren
Author:
Jae Hyun Shin
Author:
Ekta N. Bansal
Author:
Deiziane V.D.S. Costa
Author:
Xin Qun Wang
Author:
Martin Wu
Author:
Brian W. Behm
Author:
Paul V. Targonski
Author:
Laurie Archbald-Pannone
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