The Effect of Per Oral Immunotherapy in Severe IgE Mediated Egg, Milk and Nut Allergy in Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Number of the Patients That Achieve Higher Tolerance of Allergen With Immunotherapy
研究概览
简要总结
In Finland, the estimated prevalence of physician-diagnosed food allergy in 1-4 year old children is 9%, and the most common allergen is milk. The overall food allergy has been reported to be 3.7%. Hen's egg allergy is among the most common food allergies in childhood. In addition, it predicts later development of allergic disease such as asthma. Most of the egg and milk allergy is transient and disappears in childhood. Currently, the standard of care for food allergy includes strict allergen avoidance. However, oral immunotherapy has been under investigation in children milk, egg, and wheat allergy. Previously, induction of clinical egg tolerance has been reported with egg oral immunotherapy in children aged from 3 to 13 years. In adults, strict avoidance is still the standard care but there is also growing interest in treatment of severe food allergy with oral immunotherapy or anti-IgE.
The investigators aim to analyse the results of per oral immunotherapy treatment in severe IgE-mediated egg, milk, and nut allergy in adults.
Could severe egg, milk and nut allergy be treated with oral immunotherapy treatment in stead of total allergen avoidance and could desensitization thus be achieved?
详细描述
Up to 100 subjects are studied. All subjects are adults having no other severe chronic diseases. The subjects belong to four different groups:
- 30 18-50 year olds who start per oral immunotherapy treatment in severe egg allergy.
- 30 18-50 year olds who start per oral immunotherapy treatment in severe milk allergy.
- 30 18-50 year olds who start per oral immunotherapy treatment in severe nut allergy.
- 10 milk allergic 18-50 year olds that have been treated as pilot patients with milk hyposensitisation treatment.
The diagnosis of milk or egg allergy is verified with positive history, skin prick test, egg, milk and nut allergen specific IgE antibodies. In addition, food allergy is verified with an allergen specific challenge test.
Atopic subjects may have simultaneously other allergies. Intermittent mild asthma, and mild and moderate persistent asthma are tolerated and treatment with inhaled steroids and other asthma medication is allowed. Atopic subjects may have additional skin symptoms. Quality of life, anxiety and patient history data is collected by questionnaires. All patients undergo a spirometry with a bronchodilatation test, fractional exhaled nitric oxide and a methacholine challenge before and a year after oral immunotherapy. Those with test results diagnostic for asthma are treated with asthma medication before hyposensitisation treatment is started.
Exclusion criteria: adults with instable cerebrovascular or heart disease, active autoimmune disease or cancer, or use of betablocker agents. In addition, poorly controlled asthma or FEV1 < 70% are not tolerated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •severe IgE-mediated milk allergy or
- •severe IgE-mediated egg allergy or
- •severe IgE-mediated nut allergy or
- •18-50 years
排除标准
- •instable cerebrovascular or heart disease
- •active autoimmune disease or cancer
- •use of betablocker agents
- •poorly controlled asthma
- •FEV1 < 70% of the predicted
结局指标
主要结局
Number of the Patients That Achieve Higher Tolerance of Allergen With Immunotherapy
时间窗: One year
Number of the patients that achieve higher tolerance of allergen with immunotherapy in one year than the measured baseline allergen challenge shows.
次要结局
- Does the Oral Immunotherapy Have en Effect on Airway Inflammation?(One year)
- Effect of Therapy on Lung Function.(One year)
- Does Oral Immunotherapy Change Bronchial Hyperreactivity?(One year)
研究者
Paula Kauppi, MD, PhD
MD, PhD
Helsinki University Central Hospital