Basophil Activation Test to Diagnose Food Allergy

• Conditions: Egg Allergy; Food Allergy; Food Allergy in Infants; Food Allergy in Children; Food Allergen Sensitisation; Milk Allergy; Nut Allergy
• Interventions: Diagnostic Test: Oral food challenge

• Registration Number: NCT03309488
• Lead Sponsor: King's College London

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-07-07
• Study First Submitted QC: 2017-10-09
• Study First Posted: 2017-10-13
• Study Start: 2018-01-30
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-01
• Last Update Posted: 2020-09-02
• Primary Completion: 2021-07-31
• Study Completion: 2021-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

1. Children ≥6 months and <16 years old;

2. 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);

3. Avoidance of the specific food for at least 2 days prior to blood collection for BAT and specific IgE and prior to the challenge;

4. Informed consent obtained from parent or guardian and assent obtained from the child.

Exclusion Criteria

1. Clinically significant chronic illness other than atopic diseases;

2. 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;

3. Unwillingness to comply with study procedures, namely to undergo a diagnostic food challenge;

4. 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;

5. Undergoing treatment with omalizumab, food allergen immunotherapy or other systemic immunomodulatory treatment;

6. Inability to stop anti-histamines prior to SPT.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Food allergic	Oral food challenge	Patients with a positive oral challenge to the food being studied.
Non food allergic	Oral food challenge	Patients with a negative oral challenge to the food being studied.

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy of the basophil activation test (for each individual food allergy)	3 years	Accuracy of %CD63+ basophils

Secondary Outcome Measures

Name	Time	Method
Association between BAT and severity of symptoms during challenges	3 years	Correlation between %CD63+ basophils and severity grade
Association between BAT and threshold of reactivity during challenges	3 years	Correlation between CD-sens and cumulative threshold dose
Diagnostic accuracy of SPT, specific IgE to extracts and to single allergens	3 years	Accuracy of weal diameter or level of IgE

Trial Locations

Locations (1)

Pediatric Allergy Clinical Research Facility, Evelina Children's Hospital; 🇬🇧 London, United Kingdom