Trapsgewijze Ei-tolerantie-inductie Bij Kippenei-allergische Kinderen (TETI Studie)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 86
- 试验地点
- 8
- 主要终点
- time to complete egg tolerance
研究概览
简要总结
- The investigators here want to test the hypothesis that a total period of 18 months of gradual open introduction of a certain egg product with regard to full egg tolerance induction is not inferior when compared to a total period of 30 months gradual open introduction of a certain egg product (see steps for the specific egg products) after tolerance for baked egg has been obtained.
- The investigators also want to define step-specific 'tolerance-failures' and study the relevance of specific IgE to specific egg components to predict failures at each step.
详细描述
- The investigators here want to test the hypothesis that a total period of 18 months of gradual open introduction of a certain egg product with regard to full egg tolerance induction is not inferior when compared to a total period of 30 months gradual open introduction of a certain egg product (see steps for the specific egg products) after tolerance to baked egg has been obtained.
- The investigators also want to define step-specific 'tolerance-failures' and study the relevance of specific IgE to specific egg components to predict failures at each step.
Step 1: open baked egg test passed (either at home or in the hospital): this is routine clinical practice; afterwards daily intake of increasing amounts of heated egg (amounts to be noted in diary)
Step 2: open provocation test at home with hard-boiled egg, both hen's egg white and yolk, passed; afterwards weekly intake of either hard-boiled egg white or yolk or both (amounts and days to be noted in diary)
Step 3: open provocation test at home with waffles, omelet, pan cake or scrambled egg passed; afterwards weekly or two-weekly intake of one of these specific preparation forms or of the previous preparation forms (amounts, days and preparation to be noted in diary)
Step 4: open provocation test at home with fried or poached egg or softly boiled egg with liquid yolk; afterwards regular intake of one of these preparation forms or one of the prior steps (amounts, days and preparation to be noted in diary)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 12 Months 至 18 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children (1-18y) had or have a clinical diagnosis of IgE mediated hen's egg allergy based on positive history as well as skin prick testing and/or specific IgE detection by CAPtest in an allergy clinic
- •Children are at least 12 months old before introduction of heated egg is considered
- •Children did not suffer from a moderate-to-severe anaphylaxis due to egg-ingestion at presentation
- •Children have specific IgE levels to Gal d 1 below 1.2 kU/mL or passed cake provocation test -
排除标准
- •Children had a moderate-to severe anaphylaxis due to egg ingestion
- •Children are younger than 12 months old at the moment of passing heated egg open provocation test
- •Parents are not able or not willing to test a certain step in the tolerance induction at home -
结局指标
主要结局
time to complete egg tolerance
时间窗: 18 to 30 months
raw egg tolerance (eg in chocolate mousse)
次要结局
- Measurement of specific IgE to egg white components to predict complete egg tolerance(18 to 30 months)
研究者
Dominque Bullens
MD, PhD
Universitaire Ziekenhuizen KU Leuven
