Treatment of Egg Allergy in Children Through Oral Desensitization (EGG OIT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Double-blind, Placebo-controlled Food Challenge (DBPCFC) to Egg
研究概览
简要总结
The purpose of this study is to determine if children with egg allergy can be desensitized to egg protein and if this desensitization can help them outgrow their egg allergy at an earlier time than normal. Our hypothesis is that children with egg allergy can be orally desensitized to egg protein and that this desensitization will help them outgrow their egg allergy at an earlier time than normal.
详细描述
Egg allergy in children under 5 years of age is extremely common. Egg, along with milk and peanuts, cause 80% of the food allergy reactions in children in the United States. Children have allergic reactions to egg ranging from mild urticaria to systemic anaphylaxis. The current therapy for children with egg allergy is to place the child on an egg-free diet until the allergy is outgrown. Because egg protein is a part of a significant number of processed foods it is difficult to totally avoid all egg proteins. Accidental ingestions leading to reactions to egg can occur with a bite of a cookie (~70 mg of egg protein) or a bite of a cake (~55 mg of egg protein). Children typically do not outgrow their egg allergy for several years. Therefore it would be helpful if a specific form of therapy would make children outgrow their allergic reactions to egg sooner. Egg protein is given to children in this study in small increasing amounts to desensitize them to the egg protein with the goal of helping them to outgrow their allergy.
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 Year 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between 1 to 16 years of age
- •Diagnosed egg allergy by CAP FEIA to egg of 5 kU/l or greater (2 kU/l or greater if 2 years old or less) or have had a positive allergic reaction to egg within 6 months.
- •Having eaten egg in his/her diet prior to diagnosis
- •A family that will be able to be compliant with all study visits
- •All females of child bearing age must be using appropriate birth control
排除标准
- •History of anaphylaxis to egg
- •Medical history that would prevent a DBPCFC (double-blind placebo-controlled food challenge) to egg. The medical history that would prevent the DBPCFC to egg would be a prior history of an open egg challenge in which the patient experienced hypotension which required fluid resuscitation, respiratory compromise which necessitated ventilatory support, or poorly controlled asthma as evidenced by an FEV1 < 80% of predicted, or FEV1/FVC <75%, with or without controller medications
- •Unable to cooperate with challenge procedures or unable to be reached by telephone for follow-up
- •Diagnosed corn allergy
研究组 & 干预措施
Egg white protein
Subjects, who are egg allergic, are given egg white protein for desensitization with the hypothesis they will develop tolerance.
干预措施: Egg white protein (Drug)
结局指标
主要结局
Double-blind, Placebo-controlled Food Challenge (DBPCFC) to Egg
时间窗: 24-60 months
Subjects will have a double-blind, placebo-controlled food challenge (DBPCFC) to egg after at least 24 months of egg OIT when the IgE to egg is \< 7 kU/L or 90% of entry level IgE or SPT \<= 5mm with a maximum treatment period of 60 months.
次要结局
- Egg Protein Skin Prick Test After Egg OIT(24-60 months)
- Serum CAP-FEIA to Egg(24-60 months)