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临床试验/NCT02487420
NCT02487420Unknown不适用

Trapsgewijze Ei-tolerantie-inductie Bij Kippenei-allergische Kinderen (TETI Studie)

Dominque Bullens8 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2015年7月1日最近更新:
适应症

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

  1. 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.
  2. 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

  1. 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.
  2. 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

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

发起方
Dominque Bullens
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Dominque Bullens

MD, PhD

Universitaire Ziekenhuizen KU Leuven

研究点 (8)

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