Basophil Activation Test to Diagnose Food Allergy
试验速览
- 阶段
- 不适用
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy of the basophil activation test (for each individual food allergy)
研究概览
简要总结
The BAT II Study is a cross-sectional diagnostic study in which children with suspected IgE-mediated allergy to foods (namely cow's milk, egg, sesame and cashew), as defined by a history of an immediate-type allergic reaction to a food or no history of food consumption or the presence of food-specific IgE as documented by skin prick test or serum specific IgE, will undergo a diagnostic work-up to confirm or refute the diagnosis of IgE-mediated food allergy. Participants will be prospectively recruited from specialised Paediatric Allergy clinics in London and will undergo skin prick testing (SPT), specific IgE testing to allergen extracts and allergen components, basophil activation test (BAT) and oral food challenge. The diagnostic accuracy of the BAT and of other allergy tests will be assessed against the clinical gold-standard.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Months 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children ≥6 months and <16 years old;
- •Suspected IgE-mediated food allergy defined by:
- •History of an immediate-type allergic reaction to a specific food or
- •No history of consumption of the specific food or
- •IgE sensitisation documented by skin prick test (≥1 mm) or serum specific IgE (≥0.10 KU/L);
- •Avoidance of the specific food for at least 2 days prior to blood collection for BAT and specific IgE and prior to the challenge;
- •Informed consent obtained from parent or guardian and assent obtained from the child.
排除标准
- •Clinically significant chronic illness other than atopic diseases;
- •Previous history of severe life-threatening reaction to the suspected food with documented decrease in oxygen saturation (<90%), hypotension (≥20% reduction in systolic blood pressure) and/or admission to intensive care;
- •Unwillingness to comply with study procedures, namely to undergo a diagnostic food challenge;
- •Contra-indication for diagnostic food challenge, namely:
- •Uncontrolled atopic diseases (e.g. eczema, asthma, rhinitis);
- •Chronic medical conditions that pose significant risk in the event of anaphylaxis or treatment of anaphylaxis (e.g. cardiac disease, severe lung disease, pregnancy, mastocytosis);
- •Inability to discontinue medications that might interfere with assessment or safety (e.g. antihistamines, β-agonists, β-blockers, NSAIDs, ACE inhibitor, antacids);
- •Recent (within 7-14 days) treatment with systemic steroids or prolonged high-dose systemic steroids or immunosuppressants;
- •Undergoing treatment with omalizumab, food allergen immunotherapy or other systemic immunomodulatory treatment;
- •Inability to stop anti-histamines prior to SPT.
结局指标
主要结局
Diagnostic accuracy of the basophil activation test (for each individual food allergy)
时间窗: 3 years
Accuracy of %CD63+ basophils
次要结局
- Association between BAT and severity of symptoms during challenges(3 years)
- Association between BAT and threshold of reactivity during challenges(3 years)
- Diagnostic accuracy of SPT, specific IgE to extracts and to single allergens(3 years)