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
1 other identifier
observational
121
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2020
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 20, 2020
CompletedFirst Posted
Study publicly available on registry
March 24, 2020
CompletedStudy Start
First participant enrolled
May 4, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 2, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 3, 2021
CompletedMay 7, 2021
May 1, 2021
11 months
March 20, 2020
May 6, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
comparison of specific IgE kinetics between case and control patient
at inclusion
Clinical characteristics of allergic reaction
at inclusion
Clinical characteristics of patients
at inclusion
Age of clinical tolerance
at inclusion
Study Arms (2)
Angio-oedema of extremities
Patients who had revealed IgE-mediated cow milk allergy with hands and feet oedema
Without angio-oedema of extremities
Patients who had revealed IgE-mediated cow milk allergy with hands and feet oedema
Interventions
parents' telephone interview to collect medical history
Eligibility Criteria
Patient followed at the pediatric allergology consultation at the Pediatric Hospitals of Nice
You may qualify if:
- 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
You may not qualify if:
- patients without IgE specific performed in the first month after the reaction
- patients who have had only 1 documented specific IgE test
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fondation Lenvallead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 20, 2020
First Posted
March 24, 2020
Study Start
May 4, 2020
Primary Completion
April 2, 2021
Study Completion
May 3, 2021
Last Updated
May 7, 2021
Record last verified: 2021-05