NCT03309488: BAT2

Basophil Activation Test to Diagnose Food Allergy

Status unknown Last updated 2 September 2020

What this trial tests

trial testing Oral food challenge in Food Allergy in 600 participants. Status unknown.

Timeline

30 January 2018

Primary endpoint
31 July 2021

31 July 2021

Quick facts

Lead sponsor	King's College London
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	600
Start date	30 January 2018
Primary completion	31 July 2021
Estimated completion	31 July 2021
Sites	1 location across United Kingdom

Drugs / interventions tested

• Oral food challenge

Conditions studied

• Food Allergy — all drugs for Food Allergy →
• Food Allergy in Infants — all drugs for Food Allergy in Infants →
• Food Allergy in Children — all drugs for Food Allergy in Children →
• Food Allergen Sensitisation — all drugs for Food Allergen Sensitisation →

Sponsor

King's College London

Who can join

Adults 6 Months to 16, any sex, with Food Allergy or Food Allergy in Infants. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Diagnostic utility of allergy tests to predict baked egg and lightly cooked egg allergies compared to double-blind placebo-controlled food challenges.
   Krawiec M, Radulovic S, Foong RX, Marques-Mejias A, et al · · 2023 · cited 25× · PMID 37417650 · DOI 10.1111/all.15797
2. Basophil activation test as predictor of severity and threshold of allergic reactions to egg.
   Radulovic S, Foong RX, Bartha I, Marques-Mejias A, et al · · 2024 · cited 20× · PMID 37680143 · DOI 10.1111/all.15875
3. Specific IgE as the best predictor of the outcome of challenges to baked milk and baked egg.
   De Boer R, Cartledge N, Lazenby S, Tobias A, et al · · 2020 · cited 15× · PMID 31726233 · DOI 10.1016/j.jaip.2019.10.039
4. The evolution of nutritional care in children with food allergies - With a focus on cow's milk allergy.
   Meyer R, Groetch M, Santos A, Venter C. · · 2025 · cited 7× · PMID 39587736 · DOI 10.1111/jhn.13391
5. Partial Egg Consumption Modifies the Diagnostic Performance of Allergy Tests to Predict Outcome of Double-Blind Placebo-Controlled Food Challenges to Egg.
   Marques-Mejias A, Radulovic S, Foong RX, Bartha I, et al · · 2024 · cited 6× · PMID 38157981 · DOI 10.1016/j.jaip.2023.12.036
6. The Basophil Activation Test Is the Most Accurate Test in Predicting Allergic Reactions to Baked and Fresh Cow's Milk During Oral Food Challenges.
   Bartha I, Boyd H, Foong RX, Krawiec M, et al · · 2025 · cited 2× · PMID 40808324 · DOI 10.1111/all.16675
7. Basophil Activation Test as Biomarker of Severity and Threshold of Allergic Reactions to Cow's Milk During Oral Food Challenges.
   Boyd H, Bartha I, Foong RX, Krawiec M, et al · · 2026 · PMID 41410184 · DOI 10.1111/all.70175