Oral Immunotherapy for Egg Allergy in Children Aged 6 to 16
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Efficacy of oral egg immunotherapy
研究概览
简要总结
The aim of the study is to determine the efficacy of a 12-month egg oral immunotherapy (OIT) protocol with a cooked whole egg product including yolk and egg white.
Study hypothesis: With this method the risk for severe allergic reaction to egg protein is reduced and the diet can partly or completely be normalized.
详细描述
The prevalence of egg allergy among children varies from 0.5% to 3% and is thus the second most common food allergy in children. Until recently, the only treatment for egg allergy was in many cases a life-long avoidance of egg protein. Due to the large number of egg-allergic children, oral immunotherapy (OIT) to egg has been suggested to be of probable benefit to cure children with egg-allergy. Several studies have been conducted to evaluate the safety and clinical outcome of egg OIT. However, concerning efficacy and safety of egg OIT more data, and alternative procedures are required to gain a safe, simple and inexpensive immunotherapy protocol . Previous egg OIT studies have mainly used egg white in the immunotherapy, rather than more natural and inexpensive whole egg products.
The aim of this study is to determine the efficacy of a 12-month egg oral immunotherapy (OIT) protocol with a cooked whole egg product including yolk and egg white. Furthermore, the effects of whole egg OIT on humoral immune responses are investigated.
The investigators hypothesize that oral administration of a whole egg product with incremental dosing will increase the individual threshold for allergic reactivity to egg protein and may result in full tolerance without any reaction to egg.
Other study aims include investigating the differences in efficacy and side effects of whole-egg OIT in children with asthma and without asthma. In this study it is hypothesized that children with asthma have more symptoms than non-asthmatic children during the treatment. Furthemore, the level of asthma control during OIT is investigated.
The study is a prospective multicenter randomized open trial, investigating the efficacy, safety and immunological mechanisms of oral egg immunotherapy in children (aged 6 to 16). Children with egg allergy, egg avoidance diet, immediate reaction in a food challenge test for egg within the last six months and elevated serum egg-specific immunoglobulin E (IgE) levels, are recruited into the study. Children with uncontrolled asthma, severe cardiovascular disease and autoimmune disease or families with poor compliance are excluded from the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 6 to 16 years
- •Elevated spesific serum IgE to egg (> 5 kU/l) and/or positive skin prick to egg allergen
- •Positive oral food challenge for egg or anaphylaxis reaction to egg within the 6 months
- •Diet free from egg in any form
排除标准
- •Age less than 6 years or more than 16 years
- •Poor asthma control or uncontrolled asthma
- •Severe/significant cardiovascular disease
- •Autoimmune disease
- •Malignancy
- •Medication: beta bloker, angiotensin-converting-enzyme inhibitors (ACE inhibitors), Monoamine oxidase inhibitors (MAOIs)
- •Poor compliance
- •Fear of immunotherapy
- •Desensitization to alfa-gal-protein (mammalian meat allergy)
结局指标
主要结局
Efficacy of oral egg immunotherapy
时间窗: Within 12 months of study
Total number of patients who achieved tolerance to egg protein during OIT (negative egg challenge) compared to the number of patients who received only partly tolerance or failed to develop any level of unresponsiveness.
次要结局
- Safety of oral egg immunotherapy(Within 12 months of study)
- Specification of adverse reactions during egg OIT in patients without asthma(Within 12 months of study)
- Number and severity of anaphylactic reactions during OIT without asthma(Within 12 months of study)
- Number and severity of anaphylactic reactions durin OIT in patients with asthma(Within 12 months of study)
- Effect of immunotherpay on the activity of eosinophils(Within 12 months of study)
- Specification of adverse reactions during OIT in patients with asthma(Within 12 months of study)
- Effect of immunotherapy on the level of whole serum IgE(Within 12 months of study)
- Changes in parameters describing lung inflammation in patients without asthma(Within 12 months of study)
- Effect of immunotherapy on the level of specific egg IgE (sIgE)(Within 12 months of study)
- Effect of immunotherapy on white blood cells(Within 12 months of study)
- Effect of immunotherapy on the level of egg IgG4 (sIgG4)(Within 12 months of study)
- Effect of immunotherpay on heat stable, egg components(Within 12 months of study)
- Changes in parameters describing lung inflammation in patients with asthma(Within 12 months of study)
- Changes in lung function parameters during OIT in patients with asthma and > 7 years of age(Within 12 months of study)
- Changes in lung function parameters during OIT in patients with asthma < 7 years of age(Within 12 months of study)
- Changes in lung function parameters during OIT in patients without asthma and > 7 years of age(Within 12 months of study)
- Recording of asthma symptoms during egg OIT in patients with asthma(Within 12 months of study)
- Changes in lung function parameters during OIT in patients without asthma and < 7 years of age(Within 12 months of study)
- Recording of asthma symptoms during egg OIT in patients without asthma(Within 12 months of study)
研究者
Rudiger Schultz
Specialist in Pediatric Allergology
Tampere University Hospital