Food Allergy SuspectedCRDNCT06923878
Comparison of Skin Prick Testing, Extract-specific IgE Antibody Testing and Component Resolved Diagnosis in Diagnosing of Legume Allergy
An observational study of Food Allergy Suspected, run by University Hospital Pilsen at 1 site in Czechia.
Trial 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… Read more about this study
- Who is it for?
- Ages 4 months to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Food Allergy Suspected
- How many people
- 100 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Oct 2023to 31 Mar 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 months to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: European population, Caucasian race
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site, 1 recruiting
- Recruiting
University Hospital Pilsen
Pilsen, Czech Republic, 30100
Martin Liska, MD, +420377103390, liska@fnplzen.cz
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- Food Allergy Suspected
- Keywords
- food allergy, component resolved diagnosis, skin prick test, oral food challenge, legume allergy
- Medical subject headings
- Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Patients with food allergy | |
| Group 2 | Healthy volunteers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Specificity and sensitivity of the tests performed
Specificity and sensitivity of the tests performed
Measured: 6 months
Secondary outcomes (2)
Food challenge protocol
Food challenge protocol
Measured: From enrollment and no later than one.
Specific lultiplex assay including allergenic component of legumes
Specific multiplex assay including legume allergenic components
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2025
- Study start1 Oct 2023
- Primary completion1 Oct 2028 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food Allergy SuspectedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Pilsen
- Sponsor type
- University, hospital or other
- Collaborators
- MacroArray Diagnostics GmbH
- Responsible party
- Sponsor
- Investigators
- Martin Liska, MD, Principal investigator, Department of allergology and immunology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06923878
- Sponsor's protocol ID
- CRD
- Acronym
- CRD
- Status last verified
- Apr 2026
- First submitted
- 17 Mar 2025
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06923878
- Acronym / sponsor ID
- CRD / CRD
- Conditions
- Food Allergy Suspected
- Keywords
- food allergy, component resolved diagnosis, skin prick test, oral food challenge, legume allergy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital PilsenUniversity, hospital or other
- Collaborators
- MacroArray Diagnostics GmbH
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 11 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –Patients with food allergy |
| Group 2 | – | –Healthy volunteers |
Who may qualify
- Ages
- 4 months to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- European population, Caucasian race
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- disagreement with the implementation of the oral food challenge
- history of severe systemic allergic reaction to the legume in question (Ring-Messmer grade ≥ 3)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Specificity and sensitivity of the tests performed
Time frame: 6 months
Specificity and sensitivity of the tests performed
2 secondary outcomes
Food challenge protocol
Time frame: From enrollment and no later than one.
Specific lultiplex assay including allergenic component of legumes
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Food Allergy Suspected
Recruiting
Recombinant Tropomyosin- and Hemocyanin-Specific IgE in Children With Suspected Shrimp Allergy
Food Hypersensitivity, Shellfish Allergy
Not yet recruiting
Dietary Restriction Efficiency Assessment in CMPA
Cow's Milk Protein Allergy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Martin Liska, MD principal investigator
Department of allergology and immunology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Food Allergy Suspected, run by University Hospital Pilsen at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Martin Liska, MD (+420377103390, liska@fnplzen.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Specificity and sensitivity of the tests performed (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.