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NCT Number: NCT06923878

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

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.

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Key information

Age range

4 month–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Pilsen

Pilsen, Czech Republic, 30100, Czechia

Location status: Recruiting

Location contact

Martin Liska, MD

CONTACT

[email protected]

+420377103390

About this study

Legumes are one of the major food allergens, but these are usually peanuts or soybeans. Other legumes, such as peas, lentils, chickpeas or green beans, have been overlooked, but some studies suggest that they may also cause allergic reactions ranging from urticaria to anaphylaxis. The prevalence of allergy to these neglected legumes can range widely (0.5-39.6%) depending on the patient group and the method of allergy diagnosis.

The main allergens of legumes are the seed storage proteins, including 7S and 11S globulins and especially 2S albumins, which can cause the most severe, often systemic allergic reactions. These proteins are characterized by their considerable resistance to heat and other physical or chemical influences. Other important legume allergens in our geographical area are the PR-10 proteins cross-reacting with the major allergen of birch pollen (Bet v 1), which in turn are more sensitive to heat treatment and tend to be the source of milder, more local reactions. In contrast, sensitization to other allergen groups, such as lipid transfer proteins (LTPs), oleosins or profilins, is less significant.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Specificity and sensitivity of the tests performed

    Time frame: 6 months

    Specificity and sensitivity of the tests performed

Secondary outcomes

  1. Food challenge protocol

    Time frame: From enrollment and no later than one.

    Food challenge protocol

  2. Specific lultiplex assay including allergenic component of legumes

    Time frame: 6 months

    Specific multiplex assay including legume allergenic components

Study contacts

Contact information is provided by the study sponsor or research team.

Martin Liska, MD

CONTACT

[email protected]

+420377103390

Sponsors and collaborators

Lead sponsor

University Hospital Pilsen

Other

Collaborators

  • MacroArray Diagnostics GmbH

Registry information

Official study title

Comparison of Prick-to-prick Testing, Extract-specific IgE Antibody Testing and Component Resolved Diagnosis (CRD) in Diagnosing of Allergy to Peas, Lentils, Chickpeas and Green Beans

Acronym: CRD

Important dates

Study start
2023
Primary completion
2028
Study completion
2029
First posted
Apr 11, 2025
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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