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

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.

• Authors: Cirle A Warren, Jae Hyun Shin, Ekta N Bansal, Deiziane V D S Costa, Xin Qun Wang, Martin Wu, Jonathan R Swann, Brian W Behm, Paul V Targonski, Laurie Archbald-Pannone
• Journal: BMJ open (BMJ Open) Vol. 13 Issue 7 Pg. e075721 (07 19 2023) ISSN: 2044-6055 [Electronic] England
• PMID: 37474181 (Publication Type: Clinical Trial Protocol, Journal Article, Research Support, N.I.H., Extramural)
• Copyright: © 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.

Chemical References

• alanylglutamine

Topics

• Adolescent
• Humans
• Clinical Trials, Phase II as Topic
• Clostridioides difficile
• Clostridium Infections (drug therapy)
• Dietary Supplements
• Double-Blind Method
• Inflammation
• Neoplasm Recurrence, Local
• Randomized Controlled Trials as Topic
• Treatment Outcome
• Adult