New blood test may take the guesswork out of shrimp allergy diagnosis in kids
NCT ID NCT07501325
First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 1 time
Summary
This study will check if measuring IgE antibodies to two shrimp proteins (tropomyosin and hemocyanin) in the blood can accurately diagnose shrimp allergy in children. About 129 kids with suspected shrimp allergy will take part. They will have a food challenge, skin test, and blood draw. The goal is to see if these blood tests can replace or reduce the need for risky food challenges.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 129 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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Apr 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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1 year to 16 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
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A doctor treating you
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Contacts and locations
Locations
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Children's Hospital 1
RECRUITINGHo Chi Minh City, Vietnam
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