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Recruiting Observational

Comparison of Skin Prick Testing, Extract-specific IgE Antibody Testing and Component Resolved Diagnosis in Diagnosing of Legume Allergy

NCT06923878 · tracked via the Priya Life Science Czechia tracker
Phase
Observational
Started
2023-10-01
Last updated
2026-04-09

Condition(s) studied

Food Allergy Suspected

Study summary

The study is aimed at improving the diagnosis of food allergy, specifically allergy to commonly consumed legumes such as peas, lentils, chickpeas or green beans. Patients suspected of allergy to these legumes will be examined using traditional methods of IgE-mediated allergy diagnosing (skin prick test, testing for specific IgE antibodies against food extract), but also by testing for specific IgE antibodies against relevant allergenic molecules of these legumes. The results of performed tests will be compared with the result of the oral food challenge, which is considered to be the gold standard of food allergy diagnosis.

Eligibility

Sex
ALL
Min age
4 Months
Max age
65 Years
Healthy volunteers
Accepted
Inclusion Criteria: * age: ≤ 65 years * signing informed consent to the study * a positive history of an immediate allergic reaction to one or more of the legumes studied (peas, lentils, chickpeas, beans) with skin, gastrointestinal, respiratory or cardiovascular symptoms occurring within 2 hours after ingestion and a positive result of specific IgE testing against ALEX and/or skin prick test with the legume * patients with a positive OFC with any of the legumes studied Exclusion Criteria: * disagreement with the implementation of the oral food challenge * history of severe systemic allergic reaction to the legume in question (Ring-Messmer grade ≥ 3)

Primary outcome measure(s)

  • Specificity and sensitivity of the tests performed — 6 months
    Specificity and sensitivity of the tests performed

Trial sites (1)

FacilityCityRegionStatus
University Hospital Pilsen Pilsen Czech Republic Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06923878 on ClinicalTrials.gov ↗ ← All trials in Czechia