NCT01998074已完成不适用
Evaluation of the Efficacy of a New Extensively Hydrolyzed Formula in Infants With Cow's Milk Protein Allergy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 试验地点
- 2
- 主要终点
- Clinical improvement of symptoms of cow's milk protein allergy, through the use of a validated score
研究概览
简要总结
The aim of the study is to show the efficacy, tolerance and nutritional adequacy of a newly developed hydrolyzed rice formula in infants with a proven cow's milk protein allergy.
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
入排标准
- 年龄范围
- 2 Weeks 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants between 2 weeks and 6 months old
- •In whom cow's Milk Protein Allergy has been proved by a food challenge performed during the previous month
排除标准
- •Exclusively breast fed infants
- •Preterm infants
- •Infants already fed with an extensively hydrolyzed formula with no improvement of the symptoms.
- •Infants fed an amino acid based formula
- •Infants who had an anaphylactic reaction in the past
结局指标
主要结局
Clinical improvement of symptoms of cow's milk protein allergy, through the use of a validated score
时间窗: at 4 weeks
次要结局
- Clinical improvement of symptoms of cow's milk protein allergy, through the use of a validated score(at 6 months)
- Growth (weight, height, head circumference)(6 months)
研究者
研究点 (2)
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