Improved Diagnostics in Food Allergy (ID-in-FA) Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 166
- 试验地点
- 2
- 主要终点
- Test performance
研究概览
简要总结
The investigators will conduct low-dose intranasal allergen challenges on children and young people with an indeterminate diagnosis of food allergy to cow's milk or peanut. Blood samples will also be taken, for conventional blood allergy diagnostics (allergy-specific Immunoglobulin E) and mast cell activation test (MAT). The data will be used to determine the diagnostic accuracy of two complementary, novel approaches to diagnose food allergy, in a representative clinical cohort.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •IgE-sensitisation to peanut, (hen's) egg or cow's milk, with indeterminate clinical (allergy) status, defined as IgE-sensitisation below 95% positive predictive value (PPV) for diagnosis for either allergen-specific IgE or SPT, using published cut-offs OR clinician suspicion of tolerance (on basis of clinical history) despite IgE sensitisation >95% PPV cut-offs.
- •Written informed consent from parent/guardian, with assent from children aged 6 years and above wherever possible. Participants aged over 16 years will need to provide their own informed consent.
排除标准
- •Acute illness or current unstable asthma, defined as:
- •Febrile ≥38.0oC in last 72 hours
- •Acute wheeze in last 72 hours requiring treatment
- •Recent admission to hospital in preceding 2 weeks for acute asthma
- •Current medication
- •Asthma reliever medication required in preceding 72 hours
- •Recent administration of a medicine containing antihistamine within the last 3 days
- •Current oral steroid for asthma exacerbation or course completed within last 2 weeks
- •Unwilling or unable to fulfil study requirements
结局指标
主要结局
Test performance
时间窗: 1 day
Comparison of test performance characteristics (sensitivity, specificity, measured according to standard statistical methods) for each of the following diagnostic tests, compared to a formal oral food challenge (FC) as the reference standard: i. Intranasal FC (InFC) ii. Skin prick testing iii. Characterisation of serum-specific IgE to whole allergen, components and molecular components iv. Mast cell activation test (MAT) v. Basophil activation test (BAT) (peanut only)
次要结局
- Adverse events(1 day)