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.
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DOI：
10.1136/bmjopen-2023-075721
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发表时间：
2023-07-19
期刊：
影响因子：
2.9
通讯作者：
中科院分区：
文献类型：
--
作者：
艰难梭菌是美国医疗保健相关感染的主要原因，估计每年给医疗保健系统带来10亿美元的额外成本。C.艰难梭菌感染（CDI）的复发率很高，首次发作后高达25%，后续发作高达60%。初步的体外和体内研究表明，丙氨酰-谷氨酰胺（AQ）可能是有益的，在治疗CDI的作用，恢复肠上皮屏障的完整性，改善炎症和减少复发。本研究是一项随机、安慰剂对照、双盲、II期临床试验。该试验旨在确定18岁及以上患者每日口服4、24和44 g AQ的最佳剂量和安全性，同时进行非重度或重度无并发症CDI的标准治疗，持续10天。关注的主要结局是治疗后60天随访期间的CDI复发，次要结局是治疗后60天随访期间的死亡率。将进行探索性分析，以确定AQ补充对肠道和全身炎症以及肠道微生物和代谢特征的影响。该研究已获得弗吉尼亚大学机构审查委员会批准（HSR 200046，方案v9，2023年4月）。调查结果将通过会议介绍、讲座和同行评审出版物传播。NCT 04305769。
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. 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.
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美国梭菌艰难梭菌感染和结果负担的趋势。
DOI：
10.1056/nejmoa1910215
发表时间：
2020-04-02
期刊：
The New England journal of medicine
影响因子：
--
作者：
Guh AY;Mu Y;Winston LG;Johnston H;Olson D;Farley MM;Wilson LE;Holzbauer SM;Phipps EC;Dumyati GK;Beldavs ZG;Kainer MA;Karlsson M;Gerding DN;McDonald LC;Emerging Infections Program Clostridioides difficile Infection Working Group
通讯作者：
Emerging Infections Program Clostridioides difficile Infection Working Group
影响因子：
11.8
作者：
McDonald, L. Clifford;Gerding, Dale N.;Wilcox, Mark H.
通讯作者：
Wilcox, Mark H.
影响因子：
158.5
作者：
Louie, Thomas J.;Miller, Mark A.;Shue, Youe-Kong
通讯作者：
Shue, Youe-Kong
DOI：
10.1056/nejmoa1306801
发表时间：
2014-03-27
期刊：
The New England journal of medicine
影响因子：
--
作者：
Magill SS;Edwards JR;Bamberg W;Beldavs ZG;Dumyati G;Kainer MA;Lynfield R;Maloney M;McAllister-Hollod L;Nadle J;Ray SM;Thompson DL;Wilson LE;Fridkin SK;Emerging Infections Program Healthcare-Associated Infections and Antimicrobial Use Prevalence Survey Team
通讯作者：
Emerging Infections Program Healthcare-Associated Infections and Antimicrobial Use Prevalence Survey Team
影响因子：
4.5
作者：
McFarland, LV;Surawicz, CM;Greenberg, RN
通讯作者：
Greenberg, RN