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

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

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.

Study Overview

• Status: Completed
• Conditions: Milk Allergy
• Intervention / Treatment: Other: survey

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 Type: Observational
• Enrollment (Actual): 121

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 17 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patient followed at the pediatric allergology consultation at the Pediatric Hospitals of Nice

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Angio-oedema of extremities; Patients who had revealed IgE-mediated cow milk allergy with hands and feet oedema	Other: survey; parents' telephone interview to collect medical history
Without angio-oedema of extremities; Patients who had revealed IgE-mediated cow milk allergy with hands and feet oedema	Other: survey; parents' telephone interview to collect medical history

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Fondation Lenval

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 4, 2020
• Primary Completion (ACTUAL): April 2, 2021
• Study Completion (ACTUAL): May 3, 2021

Study Registration Dates

• First Submitted: March 20, 2020
• First Submitted That Met QC Criteria: March 20, 2020
• First Posted (ACTUAL): March 24, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 7, 2021
• Last Update Submitted That Met QC Criteria: May 6, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Immune System Diseases; Food Hypersensitivity; Hypersensitivity, Immediate; Skin Diseases, Vascular; Urticaria; Hypersensitivity; Milk Hypersensitivity; Angioedema
• Other Study ID Numbers: 19-HPNCL-04

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No