FARE Clinical Trial Finder
Basophil Activation Test (BAT) Sensitivity in Child Food Allergy
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.
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An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
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|Eligible Ages||6 Months - 18 Years|
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
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|University Hospital, Rouen|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Laure COUDERC, Dr|
|Principal Investigator Affiliation||UH Rouen|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Allergy to Egg, Allergy to Peanut|
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.
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