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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	4 Months - 65 Years
Gender	All

More Inclusion & Exclusion Criteria

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)

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06923878
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University Hospital Pilsen
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Martin Liska, MD
Principal Investigator Affiliation	Department of allergology and immunology
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, Industry
Overall Status	Recruiting
Countries	Czech Republic
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Food Allergy Suspected

Additional Details

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.

Arms & Interventions

Arms

: Group 1

Patients with food allergy

: Group 2

Healthy volunteers

Interventions

Contact a Trial Team

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International Sites

University Hospital Pilsen, Pilsen, Czech Republic

Status

Recruiting

Address

University Hospital Pilsen

Pilsen, , 30100

Site Contact

Martin Liska, MD

[email protected]

+420377103390

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