Effect of Therapy With Aminoacid Based Formula Versus Hydrolyzed Whey Proteins in Children With Cow's Milk Allergy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- change of z-score weight at 12 months
研究概览
简要总结
Cow's milk allergy is an immunologically mediated adverse reaction to milk proteins. In industrialized countries there is an incidence of 2-3% in children younger than 2 years. Cow's milk allergy may present with different clinical pictures and symptoms often nonspecific. Among the most common are certainly food refusal and failure to thrive until frameworks frank malnutrition. It was also noted that the cow's milk allergy can have a negative impact on the quality of life of the patient and his family.
The treatment of this condition provides the setting of a diet that is free of the allergen to the base of the adverse reaction.
There are some types of formulas for the treatment of this condition. The formulas based on amino acids are currently used in all cases non-responsive to treatment with the above formulas or in all those characterized by severe allergic reactions. Being made from amino acids such formulas are by definition non-allergenic. They have also proven to ensure a rapid resolution of symptoms favoring a resumption of growth, nutritional status, as well as lead to a rapid improvement in the quality of life of the patient and his family. However, the studies currently available to us concerning the effects of nutritional formulas based on amino acids affect short observation periods (usually less than 6 months) and were directed to a comparison only with hydrolysates of whey protein or casein and not with healthy subjects. To date thus lack consistent data on the nutritional effects in the medium to long term.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 5 Months 至 12 Months(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •subjects with diagnosis of cow's milk allergy
排除标准
- •age <5 months
- •age >12 months
- •other concomitant chronic diseases
- •malformations
- •other food allergies
结局指标
主要结局
change of z-score weight at 12 months
时间窗: after 12 months of intervention
次要结局
- change of body mass index at 12 months(after 12 months of intervention)
研究者
Roberto Berni Canani
MD, PhD
Federico II University
