NCT01940068已完成不适用
A Double-blind Randomized Controlled Trial of a Thickened Amino-acid-based Formula in Children Allergic to Cow's Milk and to Protein Hydrolysates
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Number of withdrawal for intolerance
研究概览
简要总结
The purpose of this study is to evaluate the impact of a new Amino-acid based formula on allergic symptoms and growth of infants with cow's milk protein allergy and intolerant to extensively hydrolysed formulas;
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Investigator)
入排标准
- 年龄范围
- 2 Weeks 至 18 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •less than 18 months old
- •with a proven cow's milk protein allergy by a double blind placebo controlled food challenge or a positive Skin prick test (>=6mm) or specific immunoglobulin E >= 5 kilo-unit/L or combination
- •still symptomatic while fed an extensively hydrolysed formula
排除标准
- •Exclusively breast fed infants
- •non allergic digestive enteropathy
结局指标
主要结局
Number of withdrawal for intolerance
时间窗: 1 month
次要结局
未报告次要终点
研究者
研究点 (1)
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