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益生菌对急性营养不良的幼儿微生物多样性和丰富性的影响:多中心,双盲随机受控试验的研究方案
Javeria Saleem1, Rubeena Zakar1, Sanaullah Iqbal2
1Department of Public Health, University of the Punjab, Lahore, Pakistan.
Trials
|November 27, 2024
概括
这项研究调查了益生菌对儿童严重急性营养不良 (SAM) 的影响. 益生菌与治疗性食物相结合,可以改善肠道微生物群的多样性和营养不良儿童的健康结果.
科学领域:
- 临床营养学 临床营养学
- 微生物组研究 微生物组研究
- 儿科健康 儿科健康
背景情况:
- 严重急性营养不良 (SAM) 给儿童带来了重大健康挑战.
- 益生菌为营养不良治疗提供潜在的抗炎和抗菌益处.
- 这项试验评估了益生菌在调节SAM儿童肠道微生物组中的作用.
研究的目的:
- 评估准备使用的治疗食品 (RUTF) 加上益生菌对SAM儿童肠道微生物群多样性的影响.
- 为了比较RUTF加益生菌,RUTF加粉和健康的安慰剂组之间的结果.
- 收集关于管理SAM儿童的大规模研究的数据.
主要方法:
- 前性,双盲,三臂,多中心随机对照试验.
- 招募6-59个月大的无并发性SAM儿童和健康对照.
- 主要结果:肠道微生物群的多样性;次要结果:人体测量和神经发育.
主要成果:
- 将收集有关肠道微生物群多样性的初级结果数据.
- 将收集关于体重对身高z-score,中高臂周长,神经发育和体重积累的二次结果数据.
- 安全监测每两周进行一次,数据分析遵循治疗意图原则.
结论:
- 结果将提供关于使用益生菌治疗SAM儿童的见解.
- 高质量的数据将为SAM管理的大规模研究的开发提供信息.
- 评估RUTF加益生菌对肠道微生物群多样性的影响是基于证据的干预措施的关键.
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