Gradual Egg-tolerance Induction in Hen's Egg Allergic Children Who Tolerate Baked Egg (TETI-II Study)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 62
- 试验地点
- 4
- 主要终点
- Time to complete egg tolerance
研究概览
简要总结
The investigators want to test the hypothesis that a total period of 12 months of stepwise open egg introduction is not inferior when compared to a total period of 20 months gradual open egg introduction of a certain egg product with regard to full egg tolerance induction.
详细描述
- The investigators want to test the hypothesis that a total period of 12 months of stepwise open egg introduction is not inferior when compared to a total period of 20 months gradual open egg introduction of a certain egg product (see steps for the specific egg products) with regard to full egg tolerance induction.
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 10 minutes 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 omelet, pancake 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 4 minutes 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 grade 4 anaphylaxis due to egg-ingestion at presentation (for grade 4 anaphylaxis, see EAACI anaphylaxis guidelines, Muraro A et al, Allergy. 2014 Aug;69(8):1008-25).
- •Children have specific IgE levels to Gal d 1 below 1.2 kU/mL (12-24 months) or below 5 kU/mL (>24 months) or have a level that predicts a good chance (>75%) to pass the baked egg provocation test by cake (see Bartnikas LM et al, J Allergy Clin Immunol Pract 2013; 1: 354-360) and/or children passed baked egg provocation test by cake executed on clinical judgement.
排除标准
- •Children had grade 4 anaphylaxis (for grade 4 anaphylaxis, see EAACI anaphylaxis guidelines, Muraro A et al, Allergy. 2014 Aug;69(8):1008-25) due to egg ingestion
- •Children are younger than 12 months old at the moment of passing cake open provocation test
- •Parents are not able or not willing to adhere to a certain egg step-containing diet on a regular basis at home
- •Parents and/or children are not willing to give IC/assent
研究组 & 干预措施
"Very short arm" (12 months)
Very short arm (12 months): 3 months between every step. Step by step gradual introduction of egg containing food products during 12 months, unless next step can not be taken.
干预措施: assigned period of specific dietary restrictions (Behavioral)
"Short arm" (20 months)
Short arm (20 months): 5 months between every step. Step by step gradual introduction of egg containing food products during 20 months, unless next step can not be taken.
干预措施: assigned period of specific dietary restrictions (Behavioral)
结局指标
主要结局
Time to complete egg tolerance
时间窗: 12 to 20 months
The proportion of children in each group evolving from step 1 to step 5 within the anticipated time period (12 versus 20 months), followed by 3 versus 5 months of uneventful liberal egg intake for observation after step 5.
次要结局
- The proportion of children evolving from any step to the next step within anticipated time period(3 to 5 months)
- Influence of age at inclusion in relation to the proportion of failures(12 to 20 months)
- Influence of specific IgE of hen's egg and/or components in relation to the proportion of failures(12 to 20 months)
- Influence of the dietary intake of the specific egg-containing products in relation to the proportion of failures(12 to 20 months)
- Can in vitro BAT for a certain step predict tolerance?(12 to 20 months)
- Induction of Treg over time in parallel to gradual complete hen's egg tolerance induction.(12 to 20 months)
研究者
Dominque Bullens
Clinical Professor
Universitaire Ziekenhuizen KU Leuven