FASC: Fish Allergy in Spanish Children - A Study of New Cases of Fish Allergy in Children and Adolescents

NCT07727148 | Not Yet Recruiting

• 2 other identifiers: FASC-2026-001R-0012/26
• Study Type: observational
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Fish Allergy; Food Hypersensitivity; IgE-Mediated Food Allergy

Keywords

Fish Allergy; Pediatric Allergy; Food Allergy; IgE-Mediated Allergy; Component-Resolved Diagnostics; Molecular Allergology; Specific IgE; Children; Adolescents; Anaphylaxis; Food Challenge; Quality of Life

Outcome Measures

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.

  Baseline (Day 1)

Secondary Outcomes (5)

• Sensitization to individual fish allergen components

  Baseline (Day 1)

• Specific IgE sensitization profile

  Baseline (Day 1)

• Oral food challenge outcome

  During the diagnostic evaluation (up to 3 months after baseline (Day 1))

• Health-related quality of life

  Baseline (Day 1) and at completion of the diagnostic evaluation (up to 3 months after baseline (Day 1))

• Geographical variability in sensitization profiles

  Through study completion, an average of 18 months

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Carmelo Escudero: lead

MeSH Terms

Conditions

Food Hypersensitivity; Anaphylaxis

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of the Pediatric Allergy Section, Hospital Infantil Universitario Niño Jesús

Study Record Dates

• First Submitted: July 18, 2026
• First Posted: July 27, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: July 27, 2026

Record last verified: 2026-07