Fish AllergyFASCNCT07727148
FASC: Fish Allergy in Spanish Children - A Study of New Cases of Fish Allergy in Children and Adolescents
An observational study of Fish Allergy and Food Hypersensitivity, run by Carmelo Escudero.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Fish Allergy, Food Hypersensitivity, IgE-Mediated Food Allergy
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 30 Jun 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: 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.
Read the detailed description
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.
- 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
- Medical subject headings
- Food Hypersensitivity, Anaphylaxis
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Day 1)
Secondary outcomes (5)
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.
Measured: Baseline (Day 1)
Specific IgE sensitization profile
Serum specific IgE sensitization to fish species and allergenic components determined using standardized laboratory methods.
Measured: Baseline (Day 1)
Oral food challenge outcome
Results of oral food challenges, including confirmation of clinical allergy and identification of tolerated fish species, when clinically indicated.
Measured: During the diagnostic evaluation (up to 3 months after baseline (Day 1))
Health-related quality of life
Health-related quality of life assessed using validated food allergy-specific quality-of-life questionnaires.
Measured: Baseline (Day 1) and at completion of the diagnostic evaluation (up to 3 months after baseline (Day 1))
Geographical variability in sensitization profiles
Comparison of molecular sensitization profiles and clinical characteristics across participating regions in Spain.
Measured: Through study completion, an average of 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start1 Oct 2026 (estimated)
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fish AllergyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carmelo Escudero
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Carmelo Escudero, Hospital Infantil Universitario Niño Jesús, Madrid, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07727148
- Sponsor's protocol ID
- FASC-2026-001
- Other IDs
- R-0012/26
- Acronym
- FASC
- Status last verified
- Jul 2026
- First submitted
- 18 Jul 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No