谷氨酸补充剂用于 Clostridioides difficile 感染治疗 (ACT):一项双盲随机对照试验研究协议
Cirle A Warren1, Jae Hyun Shin2, Ekta N Bansal3
1Department of Medicine, Division of Infectious Diseases and International Health, University of Virginia School of Medicine, Charlottesville, Virginia, USA ca6t@virginia.edu.
BMJ open
|July 20, 2023
概括
氨基胺 (AQ) 正在研究作为一种治疗方法,以减少Clostridioides difficile感染 (CDI) 的复发. 这一第二阶段试验评估了AQ.
科学领域:
- 胃肠病学 胃肠病学
- 传染性疾病 传染性疾病
- 临床药理学 临床药理学
背景情况:
- 艰难结核菌感染 (CDI) 是医院感染的主要原因,医疗保健成本很高,复发率很高.
- 现有的CDI治疗方法存在局限性,特别是在复发性感染方面.
- 在初步研究中,氨基胺 (AQ) 显示出改善肠道屏障功能和减少与CDI相关的炎症的潜力.
研究的目的:
- 为了评估CDI患者口服阿兰基胺 (AQ) 的最佳剂量和安全性.
- 与安慰剂相比,确定AQ在减少CDI复发中的有效性.
- 探索AQ对肠道和全身炎症以及肠道微生物群的影响.
主要方法:
- 一个随机的,安慰剂控制的,双盲的II期临床试验.
- 18岁或以上的参与者患有非严重或严重的无并发性CDI,接受了标准治疗加上口服AQ (4,24或44克每天10天) 或安慰剂.
- 主要结局:治疗后60天内CDI复发. 二次结果:60天内死亡率.
主要成果:
- 本部分应在研究结果可用后填写.
- 该研究旨在收集关于CDI复发,死亡率和炎症标志物的数据.
- 探索性分析将调查肠道和全身炎症的变化,以及微生物/代谢概况.
结论:
- 本部分应在研究结果可用后填写.
- 这些发现将告知alanil-glutamine作为CDI的辅助疗法的潜在使用.
- 进一步的研究将以该II期试验的安全性和有效性数据为指导.
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