Egg Desensitization and Induction of Tolerance in Children
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- Efficacy of desensitization in egg allergic patients as assessed by presence or absence of allergic symptoms during a blinded, placebo controlled oral food challenge
研究概览
简要总结
This study evaluates whether tolerance to eggs can be induced in patients through a process of oral immunotherapy. Participants will be randomized into groups receiving oral immunotherapy and a control group that will receive no intervention
详细描述
The investigators are proposing to initiate a study assessing a common desensitization protocol for egg allergy. This study would enable the investigators to better determine the potential benefit of desensitization in individuals with egg allergy.
More specifically, the investigators will address the following research objectives:
Objectives A. To develop a protocols for egg desensitization
B. To determine the rate of desensitization to egg.
C. To characterize predictors of successful desensitization.
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 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children 6 years and older
- •Informed consent form signed by the parents or legal guardian (appendix B).
- •A history suggestive of immediate allergy to egg. A convincing clinical history of an IgE mediated reaction to a specific food will be defined as a minimum of 2 mild signs/symptoms or 1 moderate or 1 severe sign/symptom that was likely IgE mediated and occurred within 120 minutes after ingestion or contact (or inhalation in the case of fish and shellfish). Reactions will be considered mild if they involve pruritus, urticaria, flushing, or rhinoconjunctivitis; moderate if they involve angioedema, throat tightness, gastrointestinal complaints, or breathing difficulties (other than wheeze); and severe if they involve wheeze, cyanosis, or circulatory collapse
- •Positive oral challenge test to egg. Oral challenges will be performed with Meringue Powder according to the recommendations of the position paper of the European Academy of Allergology and Clinical Immunology (68)and in an open manner (appendix C). When subjective symptoms will appear (oral pruritus, abdominal discomfort), the challenge tests will be blinded.
- •The presence of at least one of the following confirmatory tests:
- •i) Positive SPT to egg or its proteins (weal diameter 3 mm larger than that of the normal saline control). The allergens used will be commercial extracts of egg (Omega Labs, Toronto, Ontario). OR ii) Detection of serum specific IgE (>0.35 kU/L) to egg or any of its proteins (ovalbumin, ovomucoid, lysozyme and conalbumin), measured by fluorescence enzyme immunoassay (Phadia, CAP System, Uppsala, Sweden).
排除标准
- •Patients who are unstable from a respiratory point of view ..
- •Patients who present with intercurrent disease at the time of starting desensitization.
- •Non-IgE-mediated or non-immunological adverse reactions to nuts.
- •Malignant or immunopathological diseases and/or severe primary or secondary immune deficiencies.
- •Patients receiving immunosuppressor therapy
- •Patients receiving β-blockers (including topical formulations).
- •Associated diseases contraindicating the use of epinephrine: cardiovascular disease or severe hypertension.
- •Patients diagnosed with eosinophilic gastrointestinal disorder .
结局指标
主要结局
Efficacy of desensitization in egg allergic patients as assessed by presence or absence of allergic symptoms during a blinded, placebo controlled oral food challenge
时间窗: 18 months
Comparison of participants randomized to treatments arms who egg desensitization compared to participants randomized to the control group. This is measured by whether a participant is able to tolerate a total dose of 6043 mg powdered egg during an oral food challenge
次要结局
- Change from baseline over the immunotherapy process of egg specigic IgE levels(18 months)
- Change from baseline over the immunotherapy process of egg specigic IgA levels(18 months)
- Change from baseline over the immunotherapy process of Regulatory T cell levels(18 months)
- Change from baseline over the immunotherapy process of egg specigic IgG4 levels(18 months)
- Change from baseline over the immunotherapy process of of DNA methylation levels(18 months)
- Change from baseline over the immunotherapy process of mast cell activation, as measured by CD63 levels(18 months)
研究者
Bruce Mazer
Professor of Pediatrics
McGill University Health Centre/Research Institute of the McGill University Health Centre