Characteristic and Evolution of an Atypical IgE-mediated Cow Milk Allergy Form With Hands and Feet Angio-oedema

Completed

• Conditions: Milk Allergy
• Interventions: Other: survey

• Registration Number: NCT04318483
• Lead Sponsor: Fondation Lenval

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

Study Timeline

• Study First Submitted: 2020-03-20
• Study First Submitted QC: 2020-03-20
• Study First Posted: 2020-03-24
• Study Start: 2020-05-04
• Primary Completion: 2021-04-02
• Status Verified: 2021-05
• Study Completion: 2021-05-03
• Last Update Submitted: 2021-05-06
• Last Update Posted: 2021-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Without angio-oedema of extremities	survey	Patients who had revealed IgE-mediated cow milk allergy with hands and feet oedema
Angio-oedema of extremities	survey	Patients who had revealed IgE-mediated cow milk allergy with hands and feet oedema

Primary Outcome Measures

Name	Time	Method
kinetics of specific IgE	at inclusion	kinetic is defined by dosage of specific IgE (cow milk, caseine, whey proteins) from diagnostic from control to 7 months after

Secondary Outcome Measures

Name	Time	Method
Clinical characteristics of allergic reaction	at inclusion	description of cow milk allergy : associated clinical signs, kinetics of appearance of clinical signs, kinetics of disappearance, treatment undertaken
Clinical characteristics of patients	at inclusion	description of another allergy
Age of clinical tolerance	at inclusion	age of clinical tolerance is defined by age of food reintroduction at home or at hospital
comparison of specific IgE kinetics between case and control patient	at inclusion	Respective evolution of the kinetics of specific IgE directed against whey proteins and casein between T0 and T1