Study on The Oral Immune Tolerance of CMPA Infants Using Amino Acid Formula
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 主要终点
- Negative rate of open food challenge test
研究概览
简要总结
The main purpose of this study was to observe the effect of amino acid formula on infants with cow's milk protein allergy; to evaluate the role of food avoidance and Open Food Challenge test in the diagnosis of infants with cow's milk protein allergy; to observe the allergic process in infants with cow's milk protein allergy and to explore the criteria for diagnosis and treatment.
详细描述
This is a multi-center, prospective cohort study. This study plans to recruit 200 subjects. The suitable subject will be enrolled and there are seven visits through the 6-month study. Efficacy parameters are the positive incidence of open food challenge test, growth and development index (Weight, Height, Head circumference;), and the improvement of CMPA symptoms (such as SCORAD, gastrointestinal tract, respiratory, comfort scores).
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
- 1 Day 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 0 to 6 months;
- •Subject with cow's milk protein allergy (any clinical signs or symptoms of the skin, gastrointestinal tract, respiratory tract or comfortable tract)
- •Unable to breastfeed;
- •Vital signs are stable;
- •Legal guardian has signed the informed consent.
排除标准
- •Subject with congenital and hereditary metabolic diseases;
- •Digestive tract obstruction;
- •Subject with immunodeficiency diseases;
- •Subject who is allergic to known components of amino acid formula powder;
- •The investigator judges it is not suitable for the subject to participate in this study.
结局指标
主要结局
Negative rate of open food challenge test
时间窗: From baseline to AAF feeding for 6 months
Negative rate =The subjects number with negative results of open food challenge test/total subject number with open food challenge test Unit:% Negative rate range: 0-100% High negative rate indicates the immune tolerance of CMPA infant using AAF
次要结局
- HAZ(height for age Z score)(From baseline until AAF feeding for 6 months)
- Gastrointestinal symptom score(From baseline to AAF feeding for 6 months)
- Respiratory symptom score(From baseline to AAF feeding for 6 months)
- WAZ(weight for age Z score)(From baseline to AAF feeding for 6 months)
- SCORAD score(From baseline to AAF feeding for 6 months)
- Comfort symptom score(From baseline to AAF feeding for 6 months)
- HCAZ(head circumference for age Z score)(From baseline to AAF feeding for 6 months)