Randomized, Single-blinded, Prospective Clinical Trials Comparing the Impact of Legumes vs Corn-soy Flour on Environmental Enteric Dysfunction and Stunting in Rural Malawian Children 6-11 Months
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 355
- 试验地点
- 1
- 主要终点
- Change in Length-for-age z Score Over 6 Months From Enrollment to End of Study.
研究概览
简要总结
To determine if 6 months of legume-based complementary foods is effective in reducing or reversing EED and linear growth faltering in a cohort of Malawian children, aged 6-11 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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 5 Months 至 12 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 Ntenda (Chikwawa District), Malawi aged 6-11 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 Apparent need for acute medical treatment for an illness or injury Caregiver refusal to participate and return for 3 and 6 month follow-ups -
研究组 & 干预措施
Cow pea complementary food
A legume-based complementary food made from cowpeas will be given for 6 months,200 kcal/day for children 6-9 months old and 300 kcal/day for children 9-11 months old.
干预措施: Cow pea complementary food (Dietary Supplement)
Corn Soy Flour
Corn flour with 10% soy will be given for 6 months, 200 kcal/day for children 6-9 months old and 300 kcal/day for children 9-11 months old.
干预措施: Corn soy flour (Dietary Supplement)
Common bean
A legume-based complementary food made from common beans will be given for 6 months,200 kcal/day for children 6-9 months old and 300 kcal/day for children 9-11 months old.
干预措施: Common bean (Dietary Supplement)
结局指标
主要结局
Change in Length-for-age z Score Over 6 Months From Enrollment to End of Study.
时间窗: 6 months
Change in length-for-age z score from enrollment to end of study 6 months
% Lactulose From Dual Sugar Absorption Test at 9 and 12 Months of Age
时间窗: 6 month
percent of lactulose found in urine during the dual sugar absorption test
次要结局
- 16S Configuration of Fecal Microbiota at 6.5, 7.5, 9, 10.5 and 12 Months of Age Comparing Supplementary Food Groups(6 months)
- Association of 16S Configuration of Fecal Microbiome With Demographic, Anthropometric, Intestinal Permeability, Sanitation and Antibiotic Exposure Characteristics of the Study Population(6 months)
- Mid-upper Arm Circumference at 9 and 12 Months of Age(6 months)
- Weight-for-height z Score at 9 and 12 Months of Age(6 months)