Tolerability to a New Free Amino Acid-based Formula in Children With Cow's Milk Protein Allergy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 主要终点
- Study to assess the allergic symptoms, using a questionnaire.
研究概览
简要总结
It is a study to assess the tolerance to a new commercially available infant formula in children affected by Cow's Milk Allergy.
详细描述
In the present study, the children will be followed-up during the treatment with the new formula for Cow's Milk Allergy. They will have monthly doctor's appointment, when the weight, height and symptoms will be evaluated, by a questionnaire and a physical examination.
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 Day 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with cow's milk allergy
排除标准
- •Children without cow's milk allergy
结局指标
主要结局
Study to assess the allergic symptoms, using a questionnaire.
时间窗: 5 months
The allergic symptoms were assessed every month, by using a questionnaire. The parents, during the medical appointment, answered "yes" or "no" according to the presented symptoms: cutaneous (atopic dermatitis and urticaria), gastrointestinal (vomiting, diarrhea constipation and bloody stools ) and respiratory. At the end of the study the children were evaluated if they tolerated the formula, it was observed by the symptoms remission.
次要结局
- Weight assessment, using a digital infant scale(5 months)
- Height assessment, using an infantometer(5 months)
- Head circumference, using an infant tape measure(5 months)