Pilot Study on the Efficacy and Safety of an Oral Desensitization Protocol at the Onset of Food Allergy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 73
- 试验地点
- 2
- 主要终点
- number of children that completed the home oral immunotherapy protocol, reaching clinical tolerance
研究概览
简要总结
Cow's milk (CM) allergy is the most frequent food allergy in the first years of life, with prevalence rates estimated in the range of 2-3%.
The elimination of CM is the mainstay of treatment, but accidental exposure to CM proteins is not uncommon, with a considerable risk of severe allergic reactions.
Recent evidence suggests that early oral exposure in young children may protect to the development of allergy. On the same way, strategies have been developed for the use of oral exposure as immunotherapy for the treatment of children with established food allergy even if available data on the use of oral immunotherapy in infants with food allergy are very limited.
The aim of this study is to evaluate the feasibility of an oral immunotherapy protocol, started in the first year of life, in children with CM allergy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Months 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children between 3-12 months with CM allergy (defined as the association of typical clinical manifestations in the first hour after CM ingestion and evidence of sensitization of CM proteins on both skin prick test and specific serum IgE levels)
排除标准
- •children with not IgE-mediated clinical manifestations
- •children with a known immunodeficiency
研究组 & 干预措施
Oral immunotherapy protocol
Eligible children receive the oral food challenge (OCD) protocol
干预措施: Oral immunotherapy protocol (Other)
结局指标
主要结局
number of children that completed the home oral immunotherapy protocol, reaching clinical tolerance
时间窗: 6 months
Clinical tolerance defined as the achievement of a dose of 150 ml of CM or a corresponding dose of dairy products
次要结局
- Clinical reactions experienced by children at home(6 months)
- Serum levels of specific IgE(6 months)
- Serum levels of specific IgG4(6 months)