Status:
UNKNOWN
The Clinical Impact of the Basophil Activation Test to Diagnose Food Allergy
Lead Sponsor:
King's College London
Collaborating Sponsors:
Sandwell & West Birmingham Hospitals NHS Trust
Cambridge University Hospitals NHS Foundation Trust
Conditions:
Food Allergy
Food Allergy in Infants
Eligibility:
All Genders
6-15 years
Phase:
NA
Brief Summary
The BAT Impact study is a prospective multicentre study in the UK using a biomarker-led study design to compare the incidence of adverse events (defined as allergic reactions during oral food challeng...
Detailed Description
Children aged 6 months to 15 years requiring an oral food challenge to one of the study foods (milk, egg, peanut, sesame or cashew nut) will be invited to participate in the study. Eleven centres acr...
Eligibility Criteria
Inclusion
- Children and young people aged 6 months to 15 years
- Suspected allergy to one of the study foods (peanut, cow's milk, egg, cashew, sesame) - defined as:
- history of clinical reaction or
- evidence of IgE sensitisation (SPT\>0mm and/or specific IgE\>=0.10 KU/L) to the respective food or
- reassessment for possible resolution of allergy to the specific food following previous diagnosis of food allergy
- Need for an oral food challengeOFC to the study food
- Oral food challengeOFC to reach amount of food protein in a typical portion size for child's age
- Consent from adults with parental responsibility and assent from children and young people in an age appropriate form.
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 or inhalant allergen immunotherapy or other systemic immunomodulatory treatment;
- Inability to stop anti-histamines prior to SPT or OFC.
Key Trial Info
Start Date :
January 13 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2025
Estimated Enrollment :
398 Patients enrolled
Trial Details
Trial ID
NCT05309772
Start Date
January 13 2023
End Date
July 1 2025
Last Update
September 6 2023
Active Locations (11)
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1
Sandwell and West Birmingham Hospital
Birmingham, United Kingdom
2
Addenbrookes Hospital
Cambridge, United Kingdom
3
Royal Hospital for Children and Young People
Edinburgh, United Kingdom
4
Leicester Royal Infirmary
Leicester, United Kingdom