NCT02472301已完成不适用
Randomized, Single-blinded, Prospective Clinical Trial Comparing the Impact of Legumes vs Corn-soy Flour on Environmental Enteric Dysfunction and Stunting in Rural Malawian Children 1-3 Year Olds
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 337
- 试验地点
- 1
- 主要终点
- Dual Sugar Absorption Test
研究概览
简要总结
To determine if 12 months of legume-based complementary foods is effective in reducing or reversing EED and linear growth faltering in a cohort of Malawian children, aged 12-35 months to see if these improvements are correlated with specific changes in the enteric microbiome.
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
- Single (Investigator)
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 residing in catchment area of Limela, Machinga District and N tenda (Chikwawa District), Malawi
- •aged 12-35 months
- •youngest eligible child in each household
排除标准
- •Unable to drink 20 mL of sugar water
- •Demonstrating evidence of severe acute malnutrition, WHZ < or = -3, presence of bi-pedal pitting edema
- •Apparent need for acute medical treatment for an illness or injury
- •Caregiver refusal to participate and return for 3, 6 and 12 month follow-ups
结局指标
主要结局
Dual Sugar Absorption Test
时间窗: 12 months
lactulose-mannitol ratio in urine
次要结局
- Mannitol Excretion(12 months)
- Lactulose Excretion(12 months)
研究者
研究点 (1)
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