The Effect of Bovine Colostrum/ Egg Supplementation in Young Malawian Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 278
- 试验地点
- 1
- 主要终点
- Intestinal permeability
研究概览
简要总结
The trial will consist of adding either a supplement of 4.3g egg powder + 5.7g bovine colostrum or a control flour along with a multiple micronutrient powder to the diets of healthy Malawian children 9 months of age. This supplement provides additional essential amino acids, choline and immunoactive colostrum. Children will be receive either the supplement or control for 12 weeks. Children will have regular follow-up where anthropometry is measured. At enrollment and after 12 weeks, stool will be collected and a urinary lactulose permeability test conducted. Children will be measured at enrollment and at weeks 2, 4, 8, 12, 20, 32 after enrollment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 9 Months 至 10 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Children at 9-10 months of age
排除标准
- •Malnutrition
- •congenital abnormalities
- •chronic diseases such as heart disease, cerebral palsy, or HIV infection
结局指标
主要结局
Intestinal permeability
时间窗: 12 weeks
The lactulose permeability test involves drinking 20 mL of a sugar water solution and collecting urine for 4 hours thereafter
Linear growth
时间窗: 12 weeks and 32 weeks
Change in length expressed as anthropometric z-score from enrollment to end point
次要结局
- Adverse effects of the bovine colostrum/ egg(12 weeks)
- Stunting(12 and 32 weeks)
- Incidence of diarrhea(12 weeks)
- 16S configuration of fecal microbiota(12 weeks)
- Environmental enteric dysfunction(12 weeks)