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

NCT06923878 | Recruiting

• 1 other identifier: CRD
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Food Allergy Suspected

Keywords

food allergy; component resolved diagnosis; skin prick test; oral food challenge; legume allergy

Outcome Measures

Primary Outcomes (1)

• Specificity and sensitivity of the tests performed

  Specificity and sensitivity of the tests performed

  6 months

Secondary Outcomes (2)

• Food challenge protocol

  From enrollment and no later than one.

• Specific lultiplex assay including allergenic component of legumes

  6 months

Study Arms (2)

Group 1

Patients with food allergy

Group 2

Healthy volunteers

Eligibility Criteria

• Age: 4 Months - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

European population, Caucasian race

You may qualify if:

• 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

You may not qualify if:

• disagreement with the implementation of the oral food challenge
• history of severe systemic allergic reaction to the legume in question (Ring-Messmer grade ≥ 3)

Sponsors & Collaborators

• University Hospital Pilsen: lead
• MacroArray Diagnostics GmbH: collaborator

Study Sites (1)

University Hospital Pilsen

Pilsen, Czech Republic, 30100, Czechia

RECRUITING

MeSH Terms

Conditions

Food Hypersensitivity

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Martin Liska, MD

  Department of allergology and immunology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martin Liska, MD

CONTACT

+420377103390; liska@fnplzen.cz

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2025
• First Posted: April 11, 2025
• Study Start: October 1, 2023
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): March 31, 2029
• Last Updated: April 9, 2026

Record last verified: 2026-04

Locations

CZ (1)