NCT02351531已完成3 期
Cow Milk Allergy: Evaluation of the Efficacy of a New Thickened Extensively Hydrolyzed Formula in Infants With Confirmed Cow Milk Allergy
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 3
- 主要终点
- Number of patients dropped out for intolerance
研究概览
简要总结
The aim of the study is to assess the hypoallergenicity of a new thickened extensively hydrolyzed formula.
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
- 1 Month 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •between 1 and 12 months old
- •having a cow milk allergy confirmed by a positive double-blind food challenge performed in the last 3 months,
- •whose parent(s) signed the informed consent form
排除标准
- •Infants mainly or exclusively breastfed,
- •Infants having a weight at inclusion < 2500g,
- •Infants who refused to drink an extensively hydrolyzed formula anytime prior to inclusion,
- •Infants fed an amino acid based formula
- •Infants who had an anaphylactic reaction in the past,
结局指标
主要结局
Number of patients dropped out for intolerance
时间窗: 2 weeks
次要结局
- Cow's milk protein hypersensitivity score(2 weeks)
- Growth (weight, height, head circumference)(4 months)
研究者
研究点 (3)
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