Status:
UNKNOWN
Basophil Activation Test to Diagnose Food Allergy
Lead Sponsor:
King's College London
Collaborating Sponsors:
Guy's and St Thomas' NHS Foundation Trust
Conditions:
Food Allergy
Food Allergy in Infants
Eligibility:
All Genders
6-16 years
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 immedia...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
January 30 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 31 2021
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT03309488
Start Date
January 30 2018
End Date
July 31 2021
Last Update
September 2 2020
Active Locations (1)
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1
Pediatric Allergy Clinical Research Facility, Evelina Children's Hospital
London, United Kingdom, SE17EH