An interventional study of Oral Food Challenge (OFC) and Skin Prick Test in Food Hypersensitivity and Shellfish Allergy, sponsored by University of Medicine and Pharmacy at Ho Chi Minh City. Recruiting at 1 site in Vietnam. Open to participants aged 1 Year to 16 Years. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by University of Medicine and Pharmacy at Ho Chi Minh City · Not applicable, Interventional, and Diagnostic
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.
Shrimp allergy is an important cause of IgE-mediated food allergy in children, and diagnosis remains challenging because conventional tests may not reliably distinguish true clinical allergy from sensitization or cross-reactivity. Oral food challenge (OFC) remains the reference standard, but it is time-consuming, resource-intensive, and may trigger significant allergic reactions.
This interventional diagnostic study will enroll children with suspected IgE-mediated shrimp allergy. Participants will undergo OFC according to the study protocol, together with skin prick testing and blood sampling for measurement of specific IgE to recombinant tropomyosin and hemocyanin. To standardize the diagnostic procedure, OFC will be performed using black tiger shrimp (Penaeus monodon) in all participants. Additional OFCs using other shrimp species may be performed when the clinical history suggests reactions to a different shrimp species. OFC results will be used to classify participants as shrimp allergic or shrimp tolerant.
The study will estimate the proportion of true shrimp allergy among children with suspected shrimp allergy and evaluate the diagnostic performance of recombinant tropomyosin- and hemocyanin-specific IgE, alone and in combination with clinical history and skin prick test results. The findings are expected to support more accurate molecular diagnosis of shrimp allergy in children and help optimize the indication for OFC in clinical practice in Vietnam.
376 studies on the registry are indexed under Food Hypersensitivity; 90 are open to participants now.
This study's planned enrollment of 129 is above the median of 60 across 246 interventional studies indexed under Food Hypersensitivity.
Browse Food Hypersensitivity studies →University of Medicine and Pharmacy at Ho Chi Minh City is the lead sponsor of 127 studies on the registry; 44 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Exclusion Criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Children with suspected IgE-mediated shrimp allergy who undergo the study procedures, including oral food challenge, skin prick testing, and blood sampling for measurement of recombinant tropomyosin- and hemocyanin-specific IgE. Oral food challenge will be standardized using black tiger shrimp (Penaeus monodon), with additional challenge using other shrimp species when clinically indicated.
Diagnostic Test: Oral Food Challenge (OFC) · Diagnostic Test: Skin Prick Test · Diagnostic Test: Recombinant Tropomyosin- and Hemocyanin-Specific IgE Measurement
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 testing performed as part of the diagnostic evaluation in children with suspected IgE-mediated shrimp allergy.
Blood testing to measure specific IgE to recombinant tropomyosin and hemocyanin as part of the diagnostic evaluation of suspected shrimp allergy.
Oral Food Challenge-Confirmed IgE-Mediated Shrimp Allergy
Participants will be classified as having true IgE-mediated shrimp allergy if the oral food challenge is positive according to the study protocol. A negative oral food challenge indicates shrimp tolerance. Oral food challenge results will be used as the reference standard for subsequent diagnostic performance analyses.
Time frame: At the time of the oral food challenge during the baseline diagnostic evaluation
Diagnostic Accuracy of Recombinant Tropomyosin-Specific IgE for Oral Food Challenge-Confirmed Shrimp Allergy
Diagnostic performance of recombinant tropomyosin-specific IgE will be evaluated against oral food challenge results, including receiver operating characteristic analysis, area under the curve, optimal cutoff, sensitivity, specificity, positive predictive value, and negative predictive value.
Time frame: During the baseline diagnostic evaluation
Diagnostic Accuracy of Recombinant Hemocyanin-Specific IgE for Oral Food Challenge-Confirmed Shrimp Allergy
Diagnostic performance of recombinant hemocyanin-specific IgE will be evaluated against oral food challenge results, including receiver operating characteristic analysis, area under the curve, optimal cutoff, sensitivity, specificity, positive predictive value, and negative predictive value.
Time frame: During the baseline diagnostic evaluation
Diagnostic Accuracy of a Combined Model Incorporating Recombinant Tropomyosin-Specific IgE, Recombinant Hemocyanin-Specific IgE, Clinical History, and Skin Prick Test
A combined diagnostic model using recombinant tropomyosin-specific IgE, recombinant hemocyanin-specific IgE, clinical history suggestive of shrimp allergy, and skin prick test results will be evaluated against oral food challenge results. Model performance will include receiver operating characteristic analysis and area under the curve.
Time frame: During the baseline diagnostic evaluation
Plan to share: No
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Started Apr 2026 (actual). Primary completion is estimated for Mar 2028, 23 months after the start.
Of 81 non-industry interventional studies with no phase under Food Hypersensitivity, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 50. This study's planned 23 months is below that.
Counting every sponsor, half of 84 studies reached it within 29 months; a quarter within 13 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
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