NCT02925026已完成不适用
Lactoferrin and Lysozyme Supplementation for Environmental Enteric Dysfunction
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 235
- 试验地点
- 1
- 主要终点
- Dual Sugar Absorption Test
研究概览
简要总结
Randomized, double-blind, placebo controlled trial of daily lactoferrin and lysozyme supplementation in improving environmental enteric dysfunction in Malawian children
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Months 至 35 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •children aged 12-35 months
- •youngest eligible child in each household
排除标准
- •severe or moderate acute malnutrition
- •severe chronic illness
- •children unable to drink 20 mL of dual sugar solution
- •children in need of acute medical treatment for illness or injury at time of enrollment
研究组 & 干预措施
Placebo
Placebo Comparator
rice flour
干预措施: Placebo (Dietary Supplement)
Lactoferrin+Lysozyme
Experimental
lactoferrin and lysozyme in rice flour
干预措施: Lactoferrin (Dietary Supplement)
Lactoferrin+Lysozyme
Experimental
lactoferrin and lysozyme in rice flour
干预措施: Lysozyme (Dietary Supplement)
结局指标
主要结局
Dual Sugar Absorption Test
时间窗: 16 weeks
lactulose-mannitol ratio in urine
次要结局
- Lactulose Excretion(16 weeks)
- Mannitol Excretion(16 weeks)
研究者
研究点 (1)
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