FASC: Fish Allergy in Spanish Children - A Study of New Cases of Fish Allergy in Children and Adolescents (FASC)
IgE-Mediated Fish Allergy in Spanish Children and Adolescents: A Multicenter Prospective Study of New-Onset Cases and Sensitization Profiles.
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.
Studieoversikt
Status
Detaljert beskrivelse
Fish allergy is a major cause of IgE-mediated food allergy in children and is associated with a wide spectrum of clinical manifestations, ranging from mild reactions to severe anaphylaxis. Current knowledge of pediatric fish allergy is limited by geographical differences in dietary habits, fish species consumed, and patterns of allergen sensitization. Although component-resolved diagnostics have improved the characterization of fish allergy, comprehensive multicenter studies in children remain scarce.
The FASC study is a prospective, multicenter, observational study conducted in Spain to characterize children and adolescents with newly diagnosed IgE-mediated fish allergy. Consecutive eligible patients will be recruited in participating pediatric allergy units using standardized diagnostic and data collection procedures. Clinical information, allergy history, skin testing, serum specific IgE measurements, and molecular sensitization profiles will be collected. When clinically indicated, oral food challenges will be performed according to international recommendations and routine clinical practice.
The study aims to describe clinical phenotypes, molecular sensitization patterns, disease severity, quality of life, and geographical variability across Spain. The findings are expected to improve the understanding of pediatric fish allergy, support the identification of clinically relevant sensitization profiles, and contribute to more accurate diagnosis and individualized patient management.
Studietype
Registrering (Antatt)
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Children and adolescents aged 0 to 17 years (up to 18 years of age).
- First clinical episode compatible with IgE-mediated fish allergy.
- Evidence of allergic sensitization demonstrated by at least one of the following:
- 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.
- Written informed consent obtained from the parent(s) or legal guardian(s), and assent from participants aged 12 years or older, when applicable.
Exclusion Criteria:
- 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.
- Absence of informed consent or, when applicable, participant assent.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Prevalence of sensitization to clinically relevant fish allergen components.
Tidsramme: Baseline (Day 1)
|
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.
|
Baseline (Day 1)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Sensitization to individual fish allergen components
Tidsramme: Baseline (Day 1)
|
Frequency and distribution of sensitization to individual fish allergen components and allergenic protein families measured by component-resolved diagnostics.
|
Baseline (Day 1)
|
|
Specific IgE sensitization profile
Tidsramme: Baseline (Day 1)
|
Serum specific IgE sensitization to fish species and allergenic components determined using standardized laboratory methods.
|
Baseline (Day 1)
|
|
Oral food challenge outcome
Tidsramme: During the diagnostic evaluation (up to 3 months after baseline (Day 1))
|
Results of oral food challenges, including confirmation of clinical allergy and identification of tolerated fish species, when clinically indicated.
|
During the diagnostic evaluation (up to 3 months after baseline (Day 1))
|
|
Health-related quality of life
Tidsramme: Baseline (Day 1) and at completion of the diagnostic evaluation (up to 3 months after baseline (Day 1))
|
Health-related quality of life assessed using validated food allergy-specific quality-of-life questionnaires.
|
Baseline (Day 1) and at completion of the diagnostic evaluation (up to 3 months after baseline (Day 1))
|
|
Geographical variability in sensitization profiles
Tidsramme: Through study completion, an average of 18 months
|
Comparison of molecular sensitization profiles and clinical characteristics across participating regions in Spain.
|
Through study completion, an average of 18 months
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- FASC-2026-001
- R-0012/26 (Annen identifikator: Clinical Research Ethics Committee (CEIm), Hospital Infantil Universitario Niño Jesús, Madrid, Spain)
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .