Evaluation of Technical and Predictive Value of the Basophil Activation Test for Food Allergy Diagnosis in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- BAT positive and negative predictive values as compared with OFC
研究概览
简要总结
Background: The need for an oral food challenge (OFC) surrogate is growing in line with the continuous increase in the prevalence and severity of paediatric food allergy. The basophil activation test (BAT) has recently been reported as a promising tool for predicting the outcome of OFC in children.
Objective: We make the hypothesis that BAT might improve the sensitivity of food allergy diagnosis and spare part of current OFC in paediatric patients attending allergy departments in Marseille APHM University hospitals.
Methods: BAT will be performed in parallel with OFC in 100 paediatric patients receiving OFC during a diagnostic or follow-up procedure.
Expected results: Good concordance of BAT and OFC results leading to potential OFC replacement by BAT in at least 50% of the study population
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 0 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 0 - 18 years
- •Attending La Timone Paediatric Hospital for OFC
- •Social insurance
- •Parents and if possible child have received information and signed the consent form
排除标准
- •Patients not receiving an OFC
- •Lack of social insurance
- •Inability to understand the study information
- •Unwilling to participate
研究组 & 干预措施
Children receiving OFC during a diagnost
paediatric patients attending food allergy
干预措施: The basophil activation test (BAT) (Diagnostic Test)
结局指标
主要结局
BAT positive and negative predictive values as compared with OFC
时间窗: 2 years
BAT versus OFC
次要结局
- BAT quantitative results as compared with the minimal reacting dose for OFC(2 years)