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
This trial does not accept healthy volunteersQualifiers
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 population
The study population consists of children and adolescents evaluated for suspected fish allergy in the Allergy Units of participating hospitals across Spain. Participants will be recruited consecutively from routine clinical practice at tertiary referral centers that are members of the Spanish Society of Allergy and Clinical Immunology (SEAIC). The study includes patients from multiple geographical regions, providing a representative sample of the Spanish pediatric population referred for specialized allergy assessment.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Prevalence of sensitization to clinically relevant fish allergen components.
Distribution of molecular sensitization profiles to clinically relevant fish allergen components and allergenic protein families in children and adolescents with newly diagnosed IgE-mediated fish allergy, as determined by component-resolved diagnostics performed at study enrollment.
Time frame
Baseline (Day 1)Secondary outcomes
1
Sensitization to individual fish allergen components
Frequency and distribution of sensitization to individual fish allergen components and allergenic protein families measured by component-resolved diagnostics.
Time frame
Baseline (Day 1)2
Specific IgE sensitization profile
Serum specific IgE sensitization to fish species and allergenic components determined using standardized laboratory methods.
Time frame
Baseline (Day 1)3
Oral food challenge outcome
Results of oral food challenges, including confirmation of clinical allergy and identification of tolerated fish species, when clinically indicated.
Time frame
During the diagnostic evaluation (up to 3 months after baseline (Day 1))4
Health-related quality of life
Health-related quality of life assessed using validated food allergy-specific quality-of-life questionnaires.
Time frame
Baseline (Day 1) and at completion of the diagnostic evaluation (up to 3 months after baseline (Day 1))Locations
Sponsors and contacts
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Carmelo Escudero
Lead sponsor
Hospital Infantil Universitario Niño Jesús, Madrid, Spain
Sponsor institution
Source ClinicalTrials.gov
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