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Basophil Activation Test to Diagnose Food Allergy

Basophil Activation Test to Diagnose Food Allergy

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03309488
Acronym
BAT2
Enrollment
600
Registered
2017-10-13
Start date
2018-01-30
Completion date
2021-07-31
Last updated
2020-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Egg Allergy, Food Allergen Sensitisation, Food Allergy, Food Allergy in Children, Food Allergy in Infants, Milk Allergy, Nut Allergy

Keywords

Food allergy, Milk allergy, Egg allergy, Nut allergy, Basophil activation test, Diagnosis, Specific IgE, Skin prick test

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.

Interventions

DIAGNOSTIC_TESTOral food challenge

Patients with suspected food allergy will undergo clinical and dietary assessments and oral food challenge. Different allergy tests will be performed, including skin prick test, specific IgE test and basophil activation test, and its diagnostic utility will be determined against the clinical gold-standard.

Sponsors

Guy's and St Thomas' NHS Foundation Trust
CollaboratorOTHER
King's College London
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Months to 16 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic accuracy of the basophil activation test (for each individual food allergy)3 yearsAccuracy of %CD63+ basophils

Secondary

MeasureTime frameDescription
Diagnostic accuracy of SPT, specific IgE to extracts and to single allergens3 yearsAccuracy of weal diameter or level of IgE
Association between BAT and severity of symptoms during challenges3 yearsCorrelation between %CD63+ basophils and severity grade
Association between BAT and threshold of reactivity during challenges3 yearsCorrelation between CD-sens and cumulative threshold dose

Countries

United Kingdom

Contacts

Primary ContactAlexandra Santos, MD PhD
alexandra.santos@kcl.ac.uk+442071886424
Backup ContactGeorgia Hill
georgia.hill@gstt.nhs.uk+442071887188

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026