Take Away Food Allergy; Inducing Tolerance in Children Allergic to Peanut
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 77
- 试验地点
- 2
- 主要终点
- Number of participants with successfull tolerance induction to peanut
研究概览
简要总结
The purpose of the study is to identify prognostic markers and possible success rate of tolerance induction to peanut allergens in children allergic to peanut.
详细描述
The study is an open randomized controlled study on oral immunotherapy including 60 children (40 on active treatment, 20 controls) with primary peanut allergy. The study has 4 phases: 1: inclusion/randomization including a double blind placebo controlled food Challenge 2: bi weekly up-dosing to maintenance dose after 48 weeks, 3: maintenance period of 3 years 4: 1 year follow up after end of treatment.
Clinical parameters as well as immunological (serological and cellular) will be recorded at inclusion, after 3 months of up-dosing, at end of up-dosing, after 1 and 3 years of maintenance treatment and after 3 and 12 year of follow up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Positive skin prick test or IgE to peanut
- •Age 5-15 yrs
- •Primary peanut allergy verified by objective symptoms to DBPCFC by a dose of 3 mg or more peanut potein
排除标准
- •Non controlled asthma (by asthma control test, ACT)
- •Allergy/intolerance to any other ingredients in the vehicle used for the peanut DBPCFC
- •Current or previous allergen specific immunotherapy
- •Cardiac disease with increased risk of serious anaphylaxis
- •Severe atopic skin disease
- •Diabetes mellitus
- •Severe disease that interferes with adherence to study protocol
结局指标
主要结局
Number of participants with successfull tolerance induction to peanut
时间窗: Data will be recorded for 5 years
次要结局
- Clinical prognostic markers for successful tolerance induction to peanut(Data will be recorded for 5 years)
- Immunological prognostic markers for successful tolerance induction to peanut(Data will be recorded for 5 years)
研究者
Geir Håland
Consultant PhD/Post doc
Oslo University Hospital