Acceptability and Efficacy of Enterade (VS001) in Children at Risk for Environmental Enteric Dysfunction in Bangladesh
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in gastrointestinal health
研究概览
简要总结
This is a pilot study to assess the feasibility and acceptability of a trial of Enterade (VS001) to treat environmental enteric dysfunction in children from a low-income setting. Preliminary data on efficacy will also be obtained.
详细描述
Primary Objectives
- To determine tolerability of Enterade (VS001) in stunted Bangladeshi children between 1 and 2 years of age
- To assess the efficacy of Enterade (VS001) in treatment of environmental enteric dysfunction by comparing improvements in 2-h lactulose mannitol ratio between Enterade (VS001) and a placebo.
Secondary Objectives
- To assess the adherence to the regimen of 237ml (8 oz) of Enterade daily in children aged 1 to 2 years.
- To assess Enterade (VS001) efficacy by comparing improvements in fecal measures of intestinal inflammation between Enterade (VS001) and placebo.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 2 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Length-for-age Z score (LAZ) between -1 and -3 standard deviations
- •Lactulose mannitol ratio >0.09
排除标准
- •Presence of known congenital or chronic diseases other than malnutrition
- •Diarrhea (> 3 unformed stools in a 24-hour window) in the 7 days prior to screening
- •Anticipated unavailability for study visits
- •A sibling previously enrolled in this study
结局指标
主要结局
Change in gastrointestinal health
时间窗: Baseline to 14 days
Parents will complete a study specific survey which will include questions about child's gastrointestinal symptoms such as diarrhea, vomiting, nausea, bloating, or constipation to yield a gastrointestinal health score.
Change in appetite
时间窗: Baseline to 14 days
Parents will complete a study specific survey which will include questions about child's interest in food and food intake which will yield an appetite score.
Change in 2 hour Lactulose mannitol ratio
时间窗: Baseline to 14 days
Assessment of Lactulose mannitol ratio at baseline and day 14
次要结局
- Residual intervention volume(14 days)
- Fecal myeloperoxidase(14 days)
- Fecal neopterin(14 days)
- Fecal lactoferrin(14 days)
- Fecal Reg 1 beta(14 days)