Efficacy of Baked Milk in Accelerating Resolution of Cow's Milk Allergy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Tolerance to cow's milk assessed by oral food challenge test
研究概览
简要总结
To investigate the effect of baked milk in immunotherapy of cow's milk allergy.
详细描述
Food allergy, as an immune based hypersensitivity reaction, is estimated to be about 6% in young children and 3-4% in adults [1, 2]. Its pathophysiology is defined trough both IgE and non-IgE mediated mechanisms, which lead to skin, gastrointestinal, respiratory and systemic manifestations [1]. This type of allergy is mostly seen trough the first year of life. One study showed that about 2.5% of the neonates show allergy to cow's milk [3].
Most of food allergens are cow's milk, chicken egg, corn, soya, peanut, dried fruits, and fishes. Among them, cow's milk is considered to be the most common one, specifically, among the children [1, 2].
This allergen consists of about 20 proteins which all can induce immune system to produce antibodies. The two major protein components of milk are casein and whey. About 76 to 86% of it is casein, which is responsible for the IgE mediated immune response. On the other hand, whey, which is composed of alpha-lactalbumin, beta-lactoglobulin, and albumin, is mostly induced systemic allergic reactions [4].
Boiling the milk at 95 c for 20 minutes can damage some whey's protein components; however, it cannot damage the major milk's allergens. Pasteurization is also shown to have no effect on these allergens [5].
It was shown that IgE mediated mechanisms are involved in lifelong cow's milk allergy. In spite of that, about 50% of children up to 1 year old and 85% up to 3 years old develop by tolerance to milk's allergen [6].
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
- 6 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The patients' ages between 6 months to 18 years old.
- •Having positive histories of cow's milk allergy presenting by dermal, gastrointestinal, respiratory or systemic manifestations.
- •Confirmed cow's milk allergy by standard diagnostic tools such as skin prick test more than 8 millimeters or serum IgE levels higher than 5 KIU/L up to 2 years old and 15 KIU/L in other ages.
- •Cases who have tolerance to baked milk products confirmed by oral food challenge test.
排除标准
- •Ones with low serum IgE levels and negative skin prick test for milk products.
- •Ones with positive histories of unstable asthma.
- •Ones with eosinophilic gastrointestinal disorders.
- •Ones with history of allergy to baked milk products in last 6 months.
- •Ones with positive history of severe anaphylactic reaction to milk and its products in last 6 months.
- •Ones with positive allergy history to chicken egg or wheat.
- •Patients with celiac disease.
研究组 & 干预措施
Case group
The patients in case group will be received baked milk daily in the form of muffin for 6 months. They will be visited weekly in the first month and every 2 weeks in other 5 months. At the end of the 6 months, the patients will undergo oral food challenge by 30 grams baked cheese in the form of pizza cheese. If the test will be negative, they will receive pizza cheese 4 or 7 days per week for other 6 months. The patients will be followed every 2 weeks during this period.
干预措施: Baked Milk (Dietary Supplement)
结局指标
主要结局
Tolerance to cow's milk assessed by oral food challenge test
时间窗: 1 month
oral food challenge test is done for cow's milk products
次要结局
- Tolerance to cow's milk by measuring serum IgG4(1 month)
- Tolerance to cow's milk using skin prick test(1 month)
- Tolerance to cow's milk by measuring serum specific IgE levels(1 month)
研究者
Hossein Esmaielzadeh
Assisstant Professor of Asthma and Allergy
Shiraz University of Medical Sciences