Cow's Milk and Hen's Egg Hyposensitization in Adults
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 主要终点
- Number of subjects with negative results
研究概览
简要总结
Egg, milk and cereal allergies are the most important food allergies in Finnish children, the prevalence in western countries is 1-4 %. In some individuals food-allergy is maintained in to adulthood. Recent studies suggest that specific oral tolerance induction (SOTI) provides a treatment option in children with continuing allergy with high success rates. The study aims at specific oral tolerance induction in adults allergic to cow's milk or hen's egg. Oral immunotherapy involves taking very small amounts of the allergen, and slowly increasing the amount. Consequently, an elimination diet may be wholly or partially cancelled, without the fear of serious allergic reactions. Another aim is to explore changes in antibody-mediated and cell-mediated immune response to individual components of cow's milk and egg allergens during tolerance induction and compare these with the effect of the treatment.
详细描述
Background
Egg, milk and cereal allergies are the most important food allergies in Finnish children, the prevalence in western countries is 1-4 %. In some individuals food-allergy is maintained in to adulthood. The mainstay of treatment of IgE-mediated milk and egg allergy is an avoidance diet and carrying an epinephrine injector in case of an allergic reaction. Avoidance diet is very difficult and has negative effects on quality of life. Accidentally having milk or egg can cause life-threatening reactions, even lead to death. Recent studies suggest that specific oral tolerance induction (SOTI) provides a treatment option in children with continuing allergy with high success rates.
It is obvious that oral immunotherapy has impact on the milk and egg specific immune responses, but the mechanisms of this treatment have been studied only little and its effects on the cell and molecular level is practically unknown. There neither are any laboratory studies to monitor the efficacy or predict the outcome in advance or at the early stages of treatment. No research data is available on the humoral IgE, IgG4 and Immunoglobulin A (IgA) responses or the cell-mediated or cytokine responses induced by the individual major cow's milk and egg allergen components during oral immunotherapy. No tools exist for forecasting the outcome of the treatment.
Aims
The study aims at specific oral tolerance induction in adults allergic to cow's milk or hen's egg. Oral immunotherapy involves taking very small amounts of the allergen, and slowly increasing the amount. Consequently, an elimination diet may be wholly or partially cancelled, without the fear of serious allergic reactions. Another aim is to explore changes in antibody-mediated and cell-mediated immune response to individual components of cow's milk and egg allergens during tolerance induction and compare these with the effect of the treatment.
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
- 16 Years 至 65 Years(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Allergy to Egg or Cow's milk verified by challenge history and specific IgE
排除标准
- •Cardiovascular disease
- •Active immunological disease
结局指标
主要结局
Number of subjects with negative results
时间窗: 12 months after commencement
次要结局
未报告次要终点
