Using a blood test to diagnose food allergies in children
Randomised Controlled Multicentre Trial on the Clinical Impact of the Basophil Activation Test and the Mast Cell Activation Test as Food Allergy Biomarkers in Children and Young People
This study is testing a new blood test to see if it can help diagnose food allergies in children better than the usual food challenge method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 398 (estimated) |
| Ages | 6 Months to 15 Years |
| Sex | All |
| Sponsor | King's College London Academic / other |
| Drugs / interventions | omalizumab, immunotherapy |
| Locations | 11 sites (Birmingham and 10 other locations) |
| Trial ID | NCT05309772 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of the Basophil Activation Test (BAT) in diagnosing food allergies in children aged 6 months to 15 years. Participants will be randomly assigned to either the standard oral food challenge or a BAT-based strategy to determine if an oral food challenge is necessary. The study aims to compare the incidence of allergic reactions during food challenges between the two groups. It will also assess the quality of life, anxiety levels, and costs associated with the diagnostic process.
Who should consider this trial
Good fit: Ideal candidates are children aged 6 months to 15 years with suspected allergies to specific foods like milk, egg, or nuts.
Not a fit: Patients with a history of severe life-threatening reactions to suspected foods may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could reduce unnecessary oral food challenges and improve the accuracy of food allergy diagnoses in children.
How similar studies have performed: Other studies have shown promise in using biomarker-led approaches for diagnosing allergies, suggesting potential success for this method.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Birmingham and 10 other locations
- Sandwell and West Birmingham Hospital — Birmingham, United Kingdom (Recruiting)
- Addenbrookes Hospital — Cambridge, United Kingdom (Not_yet_recruiting)
- Royal Hospital for Children and Young People — Edinburgh, United Kingdom (Not_yet_recruiting)
- Leicester Royal Infirmary — Leicester, United Kingdom (Recruiting)
- Evelina London Children's Hospital — London, United Kingdom (Recruiting)
- King's College Hospital — London, United Kingdom (Not_yet_recruiting)
- University College London Hospital — London, United Kingdom (Not_yet_recruiting)
- Royal Manchester Children's Hospital — Manchester, United Kingdom (Not_yet_recruiting)
- Great North Children's Hospital — Newcastle, United Kingdom (Not_yet_recruiting)
- Sheffield Children's Hospital — Sheffield, United Kingdom (Not_yet_recruiting)
- University Hospital Southampton — Southampton, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Alexandra Santos, MD, PhD — King's College London
- Study coordinator: Alexandra Santos, MD, PhD
- Email: alexandra.santos@kcl.ac.uk
- Phone: +44 (0) 20 7188 6424
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.