Basophil Activation Test (BAT) Sensitivity in Child Food Allergy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Sensitivity of the Basophil Activation Test
研究概览
简要总结
Child food allergy represent 6 to 8% of child in industrialised country. Within this allergy, peanuts and egg allergy are one of the most common.
Actually when there is a suspicion of food allergy, the OPT is the gold standard for the diagnosis. During the OPT we give increasing doses of the allergen to the patient and evaluate threshold causing a clinical reaction. This test is associated with a risk of strong allergic reaction and need a medical supervision.
Standard allergy test, like skin test or specific IgE test, can't be use for the diagnosis of these allergy. Some publications demonstrate that these tests lack sensibility and specificity for child food allergy diagnosis.
New tests have to be develop to diagnosis child food allergy without risks. The BAT is a cellular test able to evaluate the basophiles activation by specific allergen in vitro. This test allow us to evaluate more physiologically the sensitization of patients to an allergen. It is already used in drug allergy and it has been evaluated in infant milk allergy in an other clinical trial.
In this study we want to evaluate the sensitivity of BAT to the diagnosis of child food allergy compare to the gold standard test OPT. We will evaluate the BAT on 140 children with food allergy and compare this results with the OPT at the same time. If the BAT results can predict the sensitivity of children to food allergen, it could limit the use of the OPT and reduce the risk of this test.
详细描述
Child food allergy represent 6 to 8% of child in industrialised country. One third of these child will develop severe reactions and one third will experience multiple allergy. In France, there is few epidemiologic data but in 2005 F. Rancé evaluated the prevalence of these allergy to 6.7% of school child. Within the food allergen, peanut, egg and milk are the most common.
Currently, there is two diagnostic possibilities:
- A strong allergic reaction with identified allergens and specific IgE positive, making it highly probable diagnosis.
- A moderate allergic reaction with only suspicion on the allergen, without definitive diagnosis.
When there is a suspected allergy, the gold standard to the diagnosis is the OPT. This test consist of the gradual ingestion of the suspected food allergen to evaluate the threshold causing a clinical reaction. The OPT must be performed under medical supervision in a hospital due to the risk of severe allergic reaction.
The OPT is the gold standard in allergy diagnosis. The other tests (prick test, IgE specific measure…) are not sensitive enough. Furthermore, the level of IgE specific was not related to the risk to develop clinical reaction to the food allergen. Some studies have try to combine skin tests with the result of IgE specific measure but the sensitivity did not improve enough.
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
- 6 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child older than 6 months and less than 18 years old
- •Diagnosis of type I allergy to peanut or egg
- •oral provocation test to peanut or egg programmed
排除标准
- •No possibility to assess blood sample
研究组 & 干预措施
Child food allergy suspicion
Basophil Activation Test realized in case of Child food egg and peanut allergy suspicion
干预措施: Basophil Activation Test (Biological)
结局指标
主要结局
Sensitivity of the Basophil Activation Test
时间窗: Day 1
Sensitivity of the BAT compare to OPT with a threshold value of 6% for the BAT in a population of child food allergy. Sensitivity is defined as the capacity for BAT to have a positive result when OAT result is also positive (diagnosis of allergy confirmed)
次要结局
- Evaluation of the proportion of child positive to the BAT(Day 1)