Department of Medicine, Division of Infectious Diseases and International Health, University of Virginia School of Medicine, Charlottesville, Virginia, USA
Department of Medicine, Division of Infectious Diseases and International Health, University of Virginia School of Medicine, Charlottesville, Virginia, USA.
BMJ Open. 2023 Jul 19;13(7):e075721. doi: 10.1136/bmjopen-2023-075721.
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. 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.
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.
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.
NCT04305769.
艰难梭菌（CDI）是美国医疗保健相关感染的主要原因，每年给医疗系统造成的额外成本估计超过 10 亿美元。CDI 复发率高，首次发作后高达 25%，随后发作高达 60%。初步的体外和体内研究表明，丙氨酰-谷氨酰胺（AQ）通过恢复上皮屏障的肠道完整性、改善炎症和降低复发率，可能对治疗 CDI 有益。
这是一项随机、安慰剂对照、双盲、II 期临床试验。该试验旨在确定口服 AQ 在 4、24 和 44g 剂量下的最佳剂量和安全性，每天给药 10 天，同时对 18 岁及以上非严重或严重单纯性 CDI 患者进行标准治疗。主要观察终点是治疗后 60 天随访期间的 CDI 复发，次要观察终点是治疗后 60 天随访期间的死亡率。探索性分析将确定 AQ 补充对肠道和全身炎症以及肠道微生物和代谢谱的影响。
该研究已获得弗吉尼亚大学机构审查委员会的批准（HSR200046，协议 v9，2023 年 4 月）。研究结果将通过会议演讲、讲座和同行评议的出版物进行传播。
NCT04305769。
