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

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ClinicalTrials.gov Identifier: NCT04318483
Recruitment Status : Recruiting
First Posted : March 24, 2020
Last Update Posted : July 28, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Milk Allergy 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

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Study Type : Observational
Estimated Enrollment : 64 participants
Observational Model: Case-Control
Time Perspective: Retrospective
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
Actual Study Start Date : May 4, 2020
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient followed at the pediatric allergology consultation at the Pediatric Hospitals of Nice
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 ))
  • Patients who have had a specific IgE assay at T0 (at diagnosis) and T1 (recheck 4 to 7 months after the reaction)
  • Age under 6 month at the time of the first CMA reaction
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04318483


Contacts
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Contact: Bourrier Thierry, MD 492030841 ext +33 bourrier.t@pediatrie-chulenval-nice.fr
Contact: Bonjour Sidonie sidoniebonjour@hotmail.fr

Locations
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France
Fondation Lenval Hopitaux Pediatriques de Nice Chu Lenval Recruiting
Nice, France
Contact: Thierry BOURRIER       bourrier.t@pediatrie-chulenval-nice.fr   
Contact: Sidonie BONJOUR       sidoniebonjour@hotmail.fr   
Principal Investigator: Thierry BOURRIER         
Sub-Investigator: Sidonie BONJOUR         
Sponsors and Collaborators
Fondation Lenval
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Responsible Party: Fondation Lenval
ClinicalTrials.gov Identifier: NCT04318483    
Other Study ID Numbers: 19-HPNCL-04
First Posted: March 24, 2020    Key Record Dates
Last Update Posted: July 28, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Angioedema
Hypersensitivity
Milk Hypersensitivity
Immune System Diseases
Food Hypersensitivity
Hypersensitivity, Immediate
Vascular Diseases
Cardiovascular Diseases
Urticaria
Skin Diseases, Vascular
Skin Diseases