FASC: Fish Allergy in Spanish Children - A Study of New Cases of Fish Allergy in Children and Adolescents
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 17
SponsorCarmelo Escudero
About this trial
Fish allergy is one of the leading causes of food-induced allergic reactions in children, but the clinical presentation and patterns of sensitization vary considerably among patients and geographical regions. This prospective multicenter observational study aims to characterize children and adolescents with newly diagnosed IgE-mediated fish allergy in Spain.
Clinical information, diagnostic test results, and molecular sensitization profiles will be collected using standardized procedures across participating centers. Molecular allergy assessment will include component-resolved diagnostics to evaluate sensitization to major fish allergens and other relevant allergenic protein families. The study will also assess disease severity, quality of life, and regional differences in sensitization patterns.
The results are expected to improve the understanding of pediatric fish allergy in Spain and contribute to more accurate diagnosis, risk assessment, and personalized management of affected patients.
Eligibility criteria
Qualifiers
Children and adolescents aged 0 to 17 years (up to 18 years of age).
First clinical episode compatible with IgE-mediated fish allergy.
Positive skin prick test (wheal diameter ≥3 mm compared with the negative control); or
Serum specific IgE ≥0.35 kUA/L to at least one fish species or fish allergen component.
Disqualifiers
Age ≥18 years.
Non-IgE-mediated fish allergy (e.g., fish-induced FPIES).
Severe dermographism, chronic urticaria, or severe atopic dermatitis preventing reliable interpretation of skin prick testing.
Inability to complete the diagnostic procedures required by the study.
Trial design
Treatments tested in this trial
- Not listed
Trial groups
No trial groups listed
Locations
Sponsors and collaborators
Carmelo Escudero
Lead sponsor
Hospital Infantil Universitario Niño Jesús, Madrid, Spain
Sponsor institution
Source ClinicalTrials.gov