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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age4-65
SponsorUniversity Hospital Pilsen

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

disagreement with the implementation of the oral food challenge

history of severe systemic allergic reaction to the legume in question (Ring-Messmer grade ≥ 3)

Trial population

European population, Caucasian race

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

100 Participants
are grouped into 2 trial groups
Group A: Group 1
Group B: Group 2

Trial outcomes

Primary outcomes

1

Specificity and sensitivity of the tests performed

Specificity and sensitivity of the tests performed

Time frame
6 months

Secondary outcomes

1

Food challenge protocol

Food challenge protocol

Time frame
From enrollment and no later than one.
2

Specific lultiplex assay including allergenic component of legumes

Specific multiplex assay including legume allergenic components

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital Pilsen

Lead sponsor

MacroArray Diagnostics GmbH

Collaborator