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NCT05662800
Development of Peanut, Sesame, and Tree Nut Allergy in Polish Children at High Risk of Food Allergy
Conditions: Atopic Dermatitis, Food Allergy, Peanut Allergy, Tree Nut Allergy
Sex: All
Ages: 4 Months – 36 Months
Enrollment: 240
Sponsor: Medical University of Warsaw
Location: Poland
Summary
The aim of the study is to assess the prevalence of peanut, tree nuts, and sesame allergy in Polish children at high risk of food allergy.
Additionally, the timing of the development of peanut, tree nuts and sesame allergy in the first three years of life in a high-risk population will be assessed.
Eligibility Criteria
Inclusion Criteria:moderate or severe eczema and/or egg allergy,at least one complementary food already introduced,signed informed consent.Assessment of eczema severity: Eczema severity will be assessed based on the objective SCORing Atopic Dermatitis (SCORAD), use of topical steroids, calcineurin inhibitors or systemic treatment as well as history of hospital admission.Definition of egg allergy: Participants with a documented IgE-mediated egg allergy will be identified by a convincing history of a reaction in the presence of a positive skin prick test (SPT) (wheal diameter of 3 mm or greater with egg white extract) or an SPT ≥ 5mm with no history of a reaction.Exclusion Criteria:inability to withdraw antihistamines for at least 5 days prior to testing,use of prohibited medication such as beta-blockers, angiotensin-converting-enzyme inhibitors (ACE-I) and biological treatments affecting the immunological response,uncontrolled asthma or eczema which does not warrant readiness for a food challenge within the study time frame,chronic urticaria,chronic systemic diseases.
Source: ClinicalTrials.gov (NCT05662800). StuddyBuddy aggregates publicly available trial information.