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Basophil Activation Test (BAT) Sensitivity in Child Food Allergy (TAB-TPO)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University Hospital, Rouen
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT01966640
First received: October 11, 2013
Last updated: June 18, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Allergy to Egg
Allergy to Peanut
Biological: Basophil Activation Test
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Bio-equivalence Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Basophil Activation Test (BAT) Sensitivity in Child Food Allergy

Resource links provided by NLM:


Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:
  • Sensitivity of the Basophil Activation Test [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

    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)



Secondary Outcome Measures:
  • Evaluation of the proportion of child positive to the BAT [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Evaluation of the proportion of child positive to the BAT within child positive to the OPT in the group egg allergy Evaluation of the proportion of child positive to the BAT within child positive to the OPT in the group peanut allergy


Estimated Enrollment: 140
Study Start Date: September 2013
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Child food allergy suspicion
Basophil Activation Test realized in case of Child food egg and peanut allergy suspicion
Biological: Basophil Activation Test
blood sample for Basophil Activation Test

Detailed Description:

Child food allergy represent 6 to 8% of child in industrialised country. One third of these child will develop severe reactions and one third will experience multiple allergy. In France, there is few epidemiologic data but in 2005 F. Rancé evaluated the prevalence of these allergy to 6.7% of school child. Within the food allergen, peanut, egg and milk are the most common.

Currently, there is two diagnostic possibilities:

  • A strong allergic reaction with identified allergens and specific IgE positive, making it highly probable diagnosis.
  • A moderate allergic reaction with only suspicion on the allergen, without definitive diagnosis.

When there is a suspected allergy, the gold standard to the diagnosis is the OPT. This test consist of the gradual ingestion of the suspected food allergen to evaluate the threshold causing a clinical reaction. The OPT must be performed under medical supervision in a hospital due to the risk of severe allergic reaction.

The OPT is the gold standard in allergy diagnosis. The other tests (prick test, IgE specific measure…) are not sensitive enough. Furthermore, the level of IgE specific was not related to the risk to develop clinical reaction to the food allergen. Some studies have try to combine skin tests with the result of IgE specific measure but the sensitivity did not improve enough.

New tests have to be develop to diagnosis child food allergy without risks. The BAT is a cellular test able to evaluate, in blood, the basophiles activation by specific allergen in vitro. This test measure by flow cytométrie the expression of activation molecule (CD63) on basophiles (CCR3+) after incubation with the allergen. If the patient is sensitize to the allergen, the percentage of active basophiles will be higher than in non sensitize people. This test allow us to evaluate more physiologically the sensitization of patients to an allergen. This test has already been tested for drug allergy and milk allergy in child. This clinical trial demonstrated that in mill allergy, the BAT had a good sensitivity (91% and sensibility (96%). Furthermore, this study could determined the threshold of the BAT in child food allergy (6% of activated basophiles).

In light of these results, we want to evaluate the advantage of BAT compare to OPT in child with allergy to egg or peanut.

During this study, we will perform BAT on a blood sample from child suspected of food allergy (egg or peanut) before OPT and we will compare its results with the OPT results. The primary objective of this study is to evaluate the BAT interest to predict the results of OPT by analysing the sensibility, specificity, positive predictive value, negative predictive value of BAT.

If these study demonstrate that BAT can predict OPT results for child food allergy, we will be able to reduce the number of OPT for these patients and reduce the risk of anaphylactic shock during OPT.

  Eligibility

Ages Eligible for Study:   6 Months to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • No possibility to assess blood sample
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01966640

Contacts
Contact: Laure COUDERC, Dr +3323288 ext 8265 laure.couderc@chu-rouen.fr
Contact: Julien BLOT +3323288 ext 8265 julien.blot@chu-rouen.fr

Locations
France
UH Rouen Recruiting
Rouen, France, 76031
Contact: Laure COUDERC, Dr    +3323288 ext 8265    laure.couderc@chu-rouen.fr   
Principal Investigator: Laure COUDERC, Dr         
Sponsors and Collaborators
University Hospital, Rouen
Investigators
Principal Investigator: Laure COUDERC, Dr UH Rouen
  More Information

No publications provided

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT01966640     History of Changes
Other Study ID Numbers: 2012/170/HP
Study First Received: October 11, 2013
Last Updated: June 18, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by University Hospital, Rouen:
diagnosis of allergy
Basophil Activation Test

Additional relevant MeSH terms:
Egg Hypersensitivity
Food Hypersensitivity
Hypersensitivity
Peanut Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases

ClinicalTrials.gov processed this record on November 27, 2014