Basophil Activation Test (BAT) Sensitivity in Child Food Allergy

NCT01966640 | Completed Phase 4

• 1 other identifier: 2012/170/HP
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

Child food allergy represent 6 to 8% of child in industrialised country. Within this allergy, peanuts and egg allergy are one of the most common. Actually when there is a suspicion of food allergy, the OPT is the gold standard for the diagnosis. During the OPT we give increasing doses of the allergen to the patient and evaluate threshold causing a clinical reaction. This test is associated with a risk of strong allergic reaction and need a medical supervision. Standard allergy test, like skin test or specific IgE test, can't be use for the diagnosis of these allergy. Some publications demonstrate that these tests lack sensibility and specificity for child food allergy diagnosis. New tests have to be develop to diagnosis child food allergy without risks. The BAT is a cellular test able to evaluate the basophiles activation by specific allergen in vitro. This test allow us to evaluate more physiologically the sensitization of patients to an allergen. It is already used in drug allergy and it has been evaluated in infant milk allergy in an other clinical trial. In this study we want to evaluate the sensitivity of BAT to the diagnosis of child food allergy compare to the gold standard test OPT. We will evaluate the BAT on 140 children with food allergy and compare this results with the OPT at the same time. If the BAT results can predict the sensitivity of children to food allergen, it could limit the use of the OPT and reduce the risk of this test.

Conditions

Allergy to Egg; Allergy to Peanut

Keywords

diagnosis of allergy; Basophil Activation Test

Outcome Measures

Primary Outcomes (1)

• Sensitivity of the Basophil Activation Test

  Sensitivity of the BAT compare to OPT with a threshold value of 6% for the BAT in a population of child food allergy. Sensitivity is defined as the capacity for BAT to have a positive result when OAT result is also positive (diagnosis of allergy confirmed)

  Day 1

Secondary Outcomes (1)

• Evaluation of the proportion of child positive to the BAT

  Day 1

Study Arms (1)

Child food allergy suspicion

EXPERIMENTAL

Basophil Activation Test realized in case of Child food egg and peanut allergy suspicion

Biological: Basophil Activation Test

Interventions

Basophil Activation Test BIOLOGICAL

blood sample for Basophil Activation Test

Child food allergy suspicion

Eligibility Criteria

• Age: 6 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Child older than 6 months and less than 18 years old
• Diagnosis of type I allergy to peanut or egg
• oral provocation test to peanut or egg programmed

You may not qualify if:

• No possibility to assess blood sample

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

UH Rouen

Rouen, 76031, France

Location

Related Publications (1)

• Carrette M, Couderc L, Bubenheim M, Vidal A, Youssouf A, Boyer O, Marguet C, Martinet J. The combination of Ara h 2-sIgE and basophil activation test could be an alternative to oral food challenge in cases of suspected peanut allergy. Pediatr Allergy Immunol. 2023 Aug;34(8):e14007. doi: 10.1111/pai.14007.

  PMID: 37622254 RESULT

MeSH Terms

Conditions

Peanut Hypersensitivity

Interventions

Basophil Degranulation Test

Condition Hierarchy (Ancestors)

Nut and Peanut Hypersensitivity; Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques

Study Officials

• Laure COUDERC, Dr

  UH Rouen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2013
• First Posted: October 21, 2013
• Study Start: September 12, 2013
• Primary Completion: January 11, 2019
• Study Completion: January 11, 2019
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

FR (1)