NCT03263871已完成不适用
Pilot Study of PTM202 for the Treatment of Environmental Enteric Dysfunction (EED)
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
- 200
- 试验地点
- 1
- 主要终点
- EED biomarker composite score
研究概览
简要总结
The purpose of this study is to assess the effectiveness of PTM202 in treating environmental enteric dysfunction.
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 (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 9 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 6 - 9 months old
- •-1> Weight-for-age Z score > -3
- •Parental consent to participate and receive daily supplementation with either PTM202 and/or micro-nutrient sprinkles, participate in specimen collection
排除标准
- •Presence of known kidney, liver, heart, developmental, or neurologic disease
- •Allergy to milk and/or egg (assessed by history)
- •Milk intolerance (assessed by history)
- •Abnormal liver or kidney function tests
- •Family is planning to move from the study area or children is enrolled to the other clinical trial within 3 months of follow up
- •Child being exclusively breast fed at the time of enrollment
研究组 & 干预措施
Intervention
Experimental
PTM202 and micro-nutrient sprinkles
干预措施: PTM202 (Dietary Supplement)
Intervention
Experimental
PTM202 and micro-nutrient sprinkles
干预措施: micro-nutrient sprinkles (Dietary Supplement)
Control
Other
micro-nutrient sprinkles
干预措施: micro-nutrient sprinkles (Dietary Supplement)
结局指标
主要结局
EED biomarker composite score
时间窗: 4 months
composite score of fecal Reg 1B, fecal myeloperoxidase, urinary lactulose: mannitol ratio, serum soluable-CD14, and serum C-reactive protein
次要结局
- Glucose hydrogen breath test(4 months)
- Weight gain(4 months)
- Height gain(4 months)
- Number of diarrheal episodes(4 months)
研究者
研究点 (1)
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