NCT01812629已完成不适用
Clinical Management of Children With Chronic Diarrhea
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 4
- 主要终点
- Physician determined target outcome
研究概览
简要总结
The study objective is to assess the growth, tolerance and efficacy of a complete amino acid-based medical food in children with chronic diarrhea.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 9 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Less than or equal to 9 months of age at enrollment
- •Candidates for an elemental formula
- •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 underlying GI disease with chronic diarrhea controlled by a semi-elemental or elemental formula
- •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
Physician determined target outcome
时间窗: Study Day (SD)1-84
Outcome dependent on individual subject assessment and may include decreased stool number, decreased vomiting, decreased gas, weight gain, increased caloric intake, increased protein intake, increased serum albumin concentration, increased hemoglobin concentration, better acceptance of supplemental formula.
次要结局
- Dietary Assessment(Study day (SD) 2-4, 5-7, 25-27 and 81-83)
- Gastro-Intestinal Tolerance(Study Day (SD) 2-4, 5-7, 25-27, 81-83)
- Stool characteristics(Study Day (SD) 2-4, 5-7, 25-27 and 81-83)
- Blood Chemistry(Study Day (SD) 1 and 84)
- Anthropometrics(Study Day (SD) 1, 28 and 84)
研究者
研究点 (4)
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