The Clinical Impact of the Basophil Activation Test to Diagnose Food Allergy

Launched by KING'S COLLEGE LONDON · Mar 24, 2022

Keywords

ClinConnect Summary

The BAT Impact study is a clinical trial that aims to improve how food allergies are diagnosed in children and young people. Researchers are comparing two methods: the traditional oral food challenge (OFC), where patients eat the suspected allergen to see if they have a reaction, and a new test called the basophil activation test (BAT). If the BAT shows a positive result, patients can skip the food challenge, while those with a negative result will still undergo the OFC. This study is particularly focused on common food allergies, such as those to peanuts, cow's milk, eggs, cashews, and sesame.

To participate, children and young people aged 6 months to 15 years who have a suspected allergy to one of these foods may be eligible. They should have either experienced a previous allergic reaction or shown signs of sensitization through skin or blood tests. Participants will need consent from their parents and will be asked to undergo a food challenge, which involves eating a portion of the suspected allergen in a controlled setting. It's important to note that certain medical conditions or previous severe reactions may exclude some individuals from participating. This study could help make food allergy diagnosis safer and more efficient for children.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.