FASC: Fish Allergy in Spanish Children - A Study of New Cases of Fish Allergy in Children and Ado… (NCT07727148) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
FASC: Fish Allergy in Spanish Children - A Study of New Cases of Fish Allergy in Children and Adolescents
120 participantsStarted 2026-10-01
Plain-language 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.
Who can participate
Age range
17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Prevalence of sensitization to clinically relevant fish allergen components.