Clinical trial NCT04318483: Characteristic and Evolution of an Atypical IgE-mediated Cow Milk Allergy Form With Hands and Feet Angio-oedema
Official title: Clinical and Biological Description of an Atypical IgE-mediated Cow Milk Allergy (CMA) Form With Hands and Feet Angio-oedema From the Diagnosis to Its Spontaneous Evolution and Comparison to the Typical CMA Form Without Oedema of Extremities
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Milk Allergy
Lead sponsor: Fondation Lenval
Sponsor class: OTHER
First posted: 2020-03-24
Enrollment: 121
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient followed at the pediatric allergology consultation at the Pediatric Hospitals of Nice

Brief summary: Cow milk allergy is one of the most frequent food allergy among children. Cow milk protein's avoidance is needed until spontaneous recovery during the two first years of life. A atypical clinical form with angio-oedema of hands and feet which is associated with high rate of lactoserum's IgE might be a hope of an earlier recovery.

Detailed description: Cow Milk allergy is one of the most frequent pediatric food allergy and occurs during the first months of life. It is due to an inappropriate reaction of immune system against the human body. Its treatment is the avoidance of the cow milk proteins. Its spontaneous recovery occurs mostly during the first years of life with the decreasing of the specific IgE and the clinical tolerance to cow milk proteins.

Two shorts cas reports (3 and 5 patients) have described a clinical form of IgE-mediated cow milk allergy with angio-oedema of hands and feet. This clinical form is associated with more increasing of specific IgE against lactoserum proteins than caseine's. However it has been showed that casein is a marker of cow milk allergy persistence. It might be possible that this atypical form of cow milk allergy progresses favorably towards a restoration of tolerance earlier than the clinical form without angio-oedema of the extremities

Eligibility criteria: Inclusion Criteria:

* Patients with a concordant history of IgE-mediated CMA (skin reaction within the next hours of cow milk proteins intake, regression of symptoms with avoidance of cow milk, +/- recurrence of identical symptoms when readministration)
* Patients with documented positive awareness markers (skin test and/or specific IgE \> 0,1 kilo units of allergen-specific IgE per liter (kUA/l ))
* Patient followed at the pediatric allergology consultation at the Pediatric Hospitals of Nice

Exclusion Criteria:

* patients without IgE specific performed in the first month after the reaction
* patients who have had only 1 documented specific IgE test

Primary outcomes:
measure: kinetics of specific IgE
timeFrame: at inclusion
Secondary outcomes:
measure: comparison of specific IgE kinetics between case and control patient
timeFrame: at inclusion
measure: Clinical characteristics of allergic reaction
timeFrame: at inclusion
measure: Clinical characteristics of patients
timeFrame: at inclusion
measure: Age of clinical tolerance
timeFrame: at inclusion
Other outcomes:
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