NCT01813526已完成不适用
Evaluation of an Elemental Formula in Infants With Protein Sensitive Colitis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 4
- 主要终点
- Physician Rated Symptom Score
研究概览
简要总结
Infants with protein sensitive colitis fed a nutritionally complete free amino acid-based medical food will be evaluated for 42 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- — 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Less than or equal to 6 months of age
- •36-42 weeks gestational age at birth
- •Singleton or Twin birth
- •Diagnosed with protein sensitive colitis
- •Negative stool culture at time of study entry
- •No previous history of consuming free amino acid-based medical food
- •Not receiving cisapride or steroids
- •No vitamin mineral supplement administration during the study period with the exception of iron or fluoride
- •No milk or soy products for the duration of the study
排除标准
- 未提供
结局指标
主要结局
Physician Rated Symptom Score
时间窗: Study Day (SD) 1 and 43
Calculated from a symptom checklist based on parent report of the previous 7 day history; Change in physician rated symptom score from SD 1 to SD 43.
次要结局
- Mean Rank Stool Consistency(Study Day (SD) 2-4 and 40-42)
- Weight(Study Day (SD) 1 and 43 Visits)
- Formula Intake(Study Day (SD) 2-4 and 40-42)
- Daily Stool Number(Study Day (SD) 2-4 and 40-42)
- Stool Occult Blood(Study Day (SD) 2-4 and 40-42)
研究者
研究点 (4)
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