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Phenotypical Characterization of Peanut Allergic Children

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ClinicalTrials.gov Identifier: NCT02961452
Recruitment Status : Completed
First Posted : November 11, 2016
Last Update Posted : November 11, 2016
Sponsor:
Information provided by (Responsible Party):
Lille Catholic University

Brief Summary:

Peanut allergy (PA) has been well studied and its prevalence was estimated up to 1.3% in Europe. Tree nut (TN) allergy and PA are clinically similar and often coexist, TN allergy prevalence ranged from 0.05 to 4.9 %. TN allergy is longlasting and nearly all TN have been associated with fatal allergic reactions . Other legumes or TN also contain seed storage protein orthologs of the globulins (Ara h1, Ara h 3) and 2S albumins (Ara h 2) of peanut, susceptible to provoke allergic reactions, but cross-reactivity to TN and other legumes in PA patients could also appear through primarily sensitization. These possible IgE-binding cross-reactions bring to recommend the avoidance of TN and other legumes which have never been eaten in PA children. In this context, diagnosis work-up of relevant cross-allergy versus asymptomatic cross-sensitization will impact directly children's health-related quality of life (HRQL).

When physicians suspect food allergy, many parameters have to be considered, such as clinical background, clinical history, type of symptoms related to the suspected food and cross-allergy to other foods. Then, to objectively confirm a food allergy and to assess its severity (related to the threshold reactive dose and symptoms), an oral food challenge (OFC) is demanded, and double-blind placebo-controlled food challenge (DBPCFC) is considered as "the gold standard".

Although OFC are more and more available in the diagnosis of PA, the assessment of cross-allergy to every single allergenic TN and legumes requires full allergy work-up and often many years of follow-up. Few studies investigated cross-allergy to TN and other legume, with rates of cross-allergy to TN between 28% and 50%. However, targeting patients with severe or cross-allergic phenotypes would greatly assist the allergist in management and follow-up of PA patients (i.e., planning OFC to cross-reactive food).

Our main objective is to identify different disease phenotypes of PA children with cluster analysis. This statistical approach has never been performed to identify cross-allergic phenotypes. We also will describe cross-allergy in PA and will identify possible risk factors for cross-allergy to TN and other legumes in PA children.


Condition or disease Intervention/treatment
Nut Hypersensitivity Child Legumes Allergy Tree Nut Allergy Allergy Cross Reaction Other: Cross reaction detection

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Study Type : Observational
Actual Enrollment : 317 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Phenotypical Characterization of Peanut Allergic Children With Differences in Cross-allergy to Tree Nuts and Other Legumes
Study Start Date : January 2016
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Group/Cohort Intervention/treatment
Peanut allergic children Other: Cross reaction detection



Primary Outcome Measures :
  1. Double-blind placebo-controlled food challenge Test for determination of type of allergic reaction [ Time Frame: at inclusion ]
    After the test (DBPCFC) the type of allergic reaction will be registered: asthma and allergic rhinitis (AR)

  2. Double-blind placebo-controlled food challenge Test for determination of threshold reactive dose [ Time Frame: at inclusion ]
  3. Measure of specific IgEs for the peanut component Ara h 1, Ara h 2, Ara h 3 [ Time Frame: at inclusion ]
  4. Oral food challenge test for diagnosis of tree nuts and/or other legumes allergies [ Time Frame: through the study completion ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children with peanut allergy who had a complete evaluation about cross-allergy to Tree Nuts and other legumes
Criteria

Inclusion Criteria:

  • Child evaluated at the allergy Unit of Saint Vincent Hospital of Lille (France) from March 2004 to May 2016
  • Peanut allergy proven with a double-blind placebo-controlled food challenge

Exclusion Criteria:

  • Patients who had incomplete evaluation for major peanut component at the time of their double-blind placebo-controlled food challenge to peanut.
  • All patients refusing Oral Food Challenge.

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): NCT02961452


Sponsors and Collaborators
Lille Catholic University
Investigators
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Principal Investigator: Mathias Cousin, MD GHICL

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Responsible Party: Lille Catholic University
ClinicalTrials.gov Identifier: NCT02961452     History of Changes
Other Study ID Numbers: OBS-066
First Posted: November 11, 2016    Key Record Dates
Last Update Posted: November 11, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Hypersensitivity
Nut Hypersensitivity
Immune System Diseases
Nut and Peanut Hypersensitivity
Food Hypersensitivity
Hypersensitivity, Immediate