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Recombinant Tropomyosin- and Hemocyanin-Specific IgE in Children With Suspected Shrimp Allergy

Sponsor: University of Medicine and Pharmacy at Ho Chi Minh City • ClinicalTrials.gov ID: NCT07501325

Registry updated: 2026-09-18

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Description

This study will evaluate whether blood tests that measure IgE antibodies to two shrimp proteins, tropomyosin and hemocyanin, can help diagnose shrimp allergy in children. Children with suspected IgE-mediated shrimp allergy will undergo oral food challenge, skin prick testing, and blood sampling. Oral food challenge results will be used as the reference standard to determine whether these tests can accurately identify true shrimp allergy and help improve diagnosis in clinical practice.

Interventions

Oral Food Challenge (OFC) (Diagnostic test)
Oral food challenge with shrimp performed according to the study protocol to confirm or exclude IgE-mediated shrimp allergy in children with suspected shrimp allergy. To standardize the challenge material, black tiger shrimp (Penaeus monodon) will be used in all participants. Additional oral food challenges using other shrimp species may be performed when the clinical history suggests reactions to a different shrimp species. The oral food challenge result serves as the reference standard for diagnostic evaluation in this study.
Skin Prick Test (Diagnostic test)
Skin prick testing performed as part of the diagnostic evaluation in children with suspected IgE-mediated shrimp allergy.
Recombinant Tropomyosin- and Hemocyanin-Specific IgE Measurement (Diagnostic test)
Blood testing to measure specific IgE to recombinant tropomyosin and hemocyanin as part of the diagnostic evaluation of suspected shrimp allergy.

Eligibility criteria

Inclusion Criteria: * Children aged 1 to 16 years. * Evaluated at the Allergy Unit of Children's Hospital 1. * Clinical history suggestive of IgE-mediated shrimp allergy based on EAACI 2023 criteria, including at least 1 typical allergic symptom (urticaria, angioedema, vomiting, abdominal pain, diarrhea, cough, wheezing, dyspnea, or hypotension), symptom onset within 2 hours after shrimp ingestion, and recurrence on at least 2 separate exposures. * Parent or legal guardian able to provide written informed consent; child assent obtained when appropriate. Exclusion Criteria: * Acute illness at the time of enrollment or challenge, including acute respiratory infection, acute gastrointestinal infection, or acute asthma exacerbation. * Severe chronic disease, including malignancy, severe liver or kidney disease, primary immunodeficiency, or significant heart disease affecting hemodynamic status. * Mental or behavioral disorder that prevents completion of study procedures. * Use of immunosuppressive medication (oral corticosteroids, cytotoxic drugs, or biologic agents) within 4 weeks before enrollment, or intravenous immunoglobulin within the previous 3 months. Exclusion Criteria: * Acute illness at the time of enrollment or challenge, including acute respiratory infection, acute gastrointestinal infection, or acute asthma exacerbation; participants may be rescheduled after recovery. * Severe chronic disease, including malignancy, severe liver or kidney disease, primary immunodeficiency, or significant heart disease affecting hemodynamic status. * Mental or behavioral disorder that prevents completion of study procedures. * Use of immunosuppressive medication (oral corticosteroids, cytotoxic drugs, or biologic agents) within 4 weeks before enrollment, or intravenous immunoglobulin within the previous 3 months.

Conditions

Food Hypersensitivity Shellfish Allergy

Locations

Children's Hospital 1 — Ho Chi Minh City, Vietnam

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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