NCT03309488

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 7, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 13, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

January 30, 2018

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed
Last Updated

September 2, 2020

Status Verified

September 1, 2020

Enrollment Period

3.5 years

First QC Date

July 7, 2017

Last Update Submit

September 1, 2020

Conditions

Food AllergyFood Allergy in InfantsFood Allergy in ChildrenFood Allergen SensitisationMilk AllergyEgg AllergyNut Allergy

Keywords

Food allergyMilk allergyEgg allergyNut allergyBasophil activation testDiagnosisSpecific IgESkin prick test

Outcome Measures

Primary Outcomes (1)

  • Diagnostic accuracy of the basophil activation test (for each individual food allergy)

    Accuracy of %CD63+ basophils

    3 years

Secondary Outcomes (3)

  • Diagnostic accuracy of SPT, specific IgE to extracts and to single allergens

    3 years

  • Association between BAT and severity of symptoms during challenges

    3 years

  • Association between BAT and threshold of reactivity during challenges

    3 years

Study Arms (2)

Food allergic

Patients with a positive oral challenge to the food being studied.

Diagnostic Test: Oral food challenge

Non food allergic

Patients with a negative oral challenge to the food being studied.

Diagnostic Test: Oral food challenge

Interventions

Oral food challengeDIAGNOSTIC_TEST

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.

Also known as: Basophil activation test, Skin prick test, Specific IgE test
Food allergicNon food allergic

Eligibility Criteria

Age6 Months - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Children seen in specialized Pediatric Allergy clinics with suspected allergy to one of the foods studied, namely milk, egg, sesame and nuts.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pediatric Allergy Clinical Research Facility, Evelina Children's Hospital

London, SE17EH, United Kingdom

RECRUITING

Related Publications (2)

  • Bartha I, Boyd H, Foong RX, Krawiec M, Marques-Mejias A, Marshall HF, Radulovic S, Harrison F, Antoneria G, Jama Z, Kwok M, Pietraszewicz E, Eghleilib M, Ricci C, Marrs T, Lack G, Du Toit G, Santos AF. The Basophil Activation Test Is the Most Accurate Test in Predicting Allergic Reactions to Baked and Fresh Cow's Milk During Oral Food Challenges. Allergy. 2025 Oct;80(10):2861-2873. doi: 10.1111/all.16675. Epub 2025 Aug 13.

    PMID: 40808324DERIVED

  • Marques-Mejias A, Radulovic S, Foong RX, Bartha I, Krawiec M, Kwok M, Jama Z, Harrison F, Ricci C, Lack G, Du Toit G, Santos AF. Partial Egg Consumption Modifies the Diagnostic Performance of Allergy Tests to Predict Outcome of Double-Blind Placebo-Controlled Food Challenges to Egg. J Allergy Clin Immunol Pract. 2024 Mar;12(3):660-669.e5. doi: 10.1016/j.jaip.2023.12.036. Epub 2023 Dec 27.

    PMID: 38157981DERIVED

MeSH Terms

Conditions

Food HypersensitivityMilk HypersensitivityEgg HypersensitivityNut HypersensitivityDisease

Interventions

Basophil Degranulation TestPatch Tests

Condition Hierarchy (Ancestors)

Hypersensitivity, ImmediateHypersensitivityImmune System DiseasesNut and Peanut HypersensitivityPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Immunologic TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesImmunologic TechniquesSkin Tests

Study Officials

  • Alexandra Santos, MD PhD

    King's College London

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandra Santos, MD PhD

CONTACT

+442071886424alexandra.santos@kcl.ac.uk

Georgia Hill

CONTACT

+442071887188georgia.hill@gstt.nhs.uk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2017

First Posted

October 13, 2017

Study Start

January 30, 2018

Primary Completion

July 31, 2021

Study Completion

July 31, 2021

Last Updated

September 2, 2020

Record last verified: 2020-09

Locations

GB(1)