Can specific IgE to shrimp proteins help diagnose shrimp allergy in children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional diagnostic study enrolls children aged 1 to 16 with suspected IgE-mediated shrimp allergy in Vietnam. Participants will undergo oral food challenge with black tiger shrimp, skin prick testing, and blood tests for recombinant tropomyosin- and hemocyanin-specific IgE. The oral food challenge results will serve as the reference standard to determine the accuracy of the blood tests alone and in combination with clinical history and skin tests. The goal is to improve molecular diagnosis and optimize the use of oral food challenges in clinical practice. The study will estimate the true rate of shrimp allergy among suspected cases and assess whether the two shrimp protein IgE tests can correctly identify allergic children.

Why it matters

Who can join: the full rules

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.

Where it's running

• Children's Hospital 1
  Ho Chi Minh City, Vietnam Recruiting

Study contacts

• Principal investigator: Tu HK Trinh, MD, PhD — University of Medicine and Pharmacy at Ho Chi Minh City
• Study coordinator: Ngoc Thi Nguyen, MD
• Email: ntngoc.ncs25@ump.edu.vn
• Phone: +84 908 876 976

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.