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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

Tracking Information
First Submitted Date March 20, 2020
First Posted Date March 24, 2020
Last Update Posted Date July 28, 2020
Actual Study Start Date May 4, 2020
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 4, 2020)
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
Original Primary Outcome Measures
 (submitted: March 20, 2020)
kinetics of specific IgE [ Time Frame: at inclusion ]
kinecic is defined by dosage of specific IgE (cow milk, caseine, whey proteins) from diagnosic from control to 7 months after
Change History
Current Secondary Outcome Measures
 (submitted: March 20, 2020)
  • 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
  • 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
  • Clinical characteristics of patients [ Time Frame: at inclusion ]
    description of another allergy
  • Age of clinical tolerance [ Time Frame: at inclusion ]
    age of clinical tolerance is defined by age of food reintroduction at home or at hospital
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Characteristic and Evolution of an Atypical IgE-mediated Cow Milk Allergy Form With Hands and Feet Angio-oedema
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
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 Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patient followed at the pediatric allergology consultation at the Pediatric Hospitals of Nice
Condition Milk Allergy
Intervention Other: survey
parents' telephone interview to collect medical history
Study Groups/Cohorts
  • Angio-oedema of extremities
    Patients who had revealed IgE-mediated cow milk allergy with hands and feet oedema
    Intervention: Other: survey
  • Without angio-oedema of extremities
    Patients who had revealed IgE-mediated cow milk allergy with hands and feet oedema
    Intervention: Other: survey
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 20, 2020)
64
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 2021
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages up to 17 Years   (Child)
Accepts Healthy Volunteers No
Contacts
Contact: Bourrier Thierry, MD 492030841 ext +33 bourrier.t@pediatrie-chulenval-nice.fr
Contact: Bonjour Sidonie sidoniebonjour@hotmail.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT04318483
Other Study ID Numbers 19-HPNCL-04
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Fondation Lenval
Study Sponsor Fondation Lenval
Collaborators Not Provided
Investigators Not Provided
PRS Account Fondation Lenval
Verification Date July 2020