NCT02317952已完成不适用
A Double-Blind, Randomized, Crossover Allergy Study of an Experimental Formula Followed by a 16 Week Double Blind Feeding Period to Assess Growth, Safety and Development of Tolerance to Cow's Milk Protein
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 36
- 主要终点
- Incidence of Allergic Reaction
研究概览
简要总结
The purpose of this study is to determine if a new extensively hydrolyzed formula can be consumed by children with Cow's Milk Allergy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Good health
- •Parent/guardian must be willing to provide informed consent
- •Parent/guardian agrees to feed study formula provided
- •Confirmation of Cow's Milk Allergy
排除标准
- •No clinically significant abnormal findings on medical history, laboratory results, and physical exam.
- •No medications that may interfere with or impact evaluation of the study assessments
- •Allergy to extensively hydrolyzed casein formula
- •Tolerance of 200 ml of cow's milk, cow's milk-based formula or food products containing intact cow's milk protein within 2 weeks of the Screening Visit
- •Participation in another clinical trial within 30 days of screening where they are are receiving an active intervention
结局指标
主要结局
Incidence of Allergic Reaction
时间窗: 2 weeks
次要结局
- Growth(16 weeks)
研究者
研究点 (36)
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