NCT01820494已完成不适用
Nutritional Management of Infants With Chronic Diarrhea
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 6
- 主要终点
- Weight
研究概览
简要总结
The study objective is to assess the growth of infants fed an experimental formula for the nutritional management of chronic diarrhea.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- — 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Less than or equal to 12 months of age at enrollment
- •Candidates for elemental feeding
- •Chronic diarrhea and diagnosis of one of the following conditions: short-bowel syndrome, eosinophilic gastroenteritis, food allergy, inflammatory bowel disease, pancreatic disease, protein maldigestion, HIV-advanced disease or other GI disease requiring an elemental diet or have underlying GI disease without chronic diarrhea if his/her chronic diarrhea is controlled or is in remission by a semi-elemental or elemental formula for no more than 13 weeks
- •Parents agree to feed infant with experimental formula for least 50% of total calories during study period
排除标准
- •Any non-approved concomitant study
结局指标
主要结局
Weight
时间窗: Study Day (SD) 1, 28 and 84
Change in weight from baseline.
次要结局
- Stool Characteristics(Study Day (SD) 2-4, 5-7, 25-27 and 81-83)
研究者
研究点 (6)
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