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OpenTrials
Completed

NCT Number: NCT04318483

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

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.

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Key information

Age range

Up to 17 year

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Survey

Other

parents' telephone interview to collect medical history

Primary outcomes

  1. kinetics of specific IgE

    Time frame: at inclusion

    kinetic is defined by dosage of specific IgE (cow milk, caseine, whey proteins) from diagnostic from control to 7 months after

Secondary outcomes

  1. comparison of specific IgE kinetics between case and control patient

    Time frame: at inclusion

    Respective evolution of the kinetics of specific IgE directed against whey proteins and casein between T0 and T1

  2. Clinical characteristics of allergic reaction

    Time frame: at inclusion

    description of cow milk allergy : associated clinical signs, kinetics of appearance of clinical signs, kinetics of disappearance, treatment undertaken

  3. Clinical characteristics of patients

    Time frame: at inclusion

    description of another allergy

  4. Age of clinical tolerance

    Time frame: at inclusion

    age of clinical tolerance is defined by age of food reintroduction at home or at hospital

Sponsors and collaborators

Lead sponsor

Fondation Lenval

Other

Registry information

Official study 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

Acronym: IgE-CMA

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 24, 2020
Registry last updated
May 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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