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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-16
SponsorUniversity of Medicine and Pharmacy at Ho Chi Minh City

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Oral Food Challenge (OFC)
  • Skin Prick Test
  • Recombinant Tropomyosin- and Hemocyanin-Specific IgE Measurement

Treatment groups

129 Participants
are divided into 1 treatment group

Sponsors and collaborators

University of Medicine and Pharmacy at Ho Chi Minh City

Lead sponsor

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

Collaborator