Trophallergen Prick Tests (PT) : Influence of Food Sample Shelf Life on the Reproducibility of PT Results
NCT ID: NCT06872996
Last Updated: 2025-12-30
Study Results
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Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2025-04-10
2027-10-10
Brief Summary
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This method, performed with native foods (unprocessed food, uncontaminated foods), either raw or cooked (depending on the nature of the allergen being tested), is preferred over the use of commercial extracts (standardized commercial allergen preparations) due to its better sensitivity and specificity, the high cost of commercial extracts, and the lack of commercial extracts for certain foods. For practical reasons, given the wide variety of possible allergens, and to most accurately reproduce the exposure that caused the reaction, the most common approach is to ask the patient to bring their own foods for testing. These foods should be brought in a fresh state. However, situations where the patient is offered a food PT but does not have fresh native foods are common. Indeed, many patients forget to bring them. Similarly, during a consultation to explore a respiratory or drug allergy, the interview may lead to the detection of a food allergy that needs to be tested at the same time. Given the delays in allergology consultations, the severity of food allergy symptoms, and the potential risk of delayed diagnosis, all allergists involved in managing food allergies are led to create a library of food samples stored either in a dry state (e.g., nuts, peanuts, cereal flours) or frozen for perishable foods (meats, shellfish, fruits, vegetables). To our knowledge, after reviewing the literature, no guidelines for best practices regarding the storage of these food samples for PT purposes have been established by scientific societies. Moreover, while the impact of freezing and thawing methods on the denaturation of food proteins is known, the effect of freezing and its duration on the sensitivity and specificity of PT is poorly understood.
The objective of our study is to evaluate the reproducibility of PT results between those performed with fresh foods and those performed with preserved foods at different storage dates in participants who have experienced anaphylaxis of at least grade 2 according to the Ring and Messmer classification.
Detailed Description
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A native food is a raw food not contaminated by other foods. It is said to be fresh if it has not been subject to a prolonged preservation technique such as freezing or canning. The native food can be raw or cooked depending on the nature of the food and the nature of the allergic protein tested.
In our study the patient is his own witness. Carrying out all tests in a single session makes it possible to avoid analysis biases related to intra-individual variabilities in reactivity encountered during prick tests carried out on different dates (patient included only once in the study, no re-inclusion possible). In our study, several foods can be tested for the same patient depending on the number of food allergies that the patient has.
The completion of the study does not change the follow up methods for patients who are already offered prick tests as part of their allergic pathology. The study lasts approximately 30 minutes for each patient, while the prick tests are carried out. Their follow up is carried out by nurses of the allergology department for 30 minutes from the completion of the prick tests and this, under the responsibility of the allergist doctor of the department whose presence is obligatory when performing these tests.
Participants will be fully and honestly informed, in understandable terms, about the objectives and constraints of the study, the potential risks incurred, the necessary monitoring and safety measures, and their rights to refuse to participate in the study or to withdraw at any time.
All this information is provided in an information form given to the patient. The patient's written consent will be obtained by the investigator, a junior doctor, or a representative doctor before any procedure specific to the study.
As this is a pilot, exploratory, monocentric study, and given that Orléans University Hospital receives approximately 50 patients per year (who meet the eligibility criteria), it is planned to include 100 patients in the study over a maximum period of 30 months.
A clinical research associate (ARC) mandated by the sponsor will ensure the proper conduct of the study, the collection of generated data, its documentation, recording, and reporting, in accordance with the Standard Operating Procedures implemented within Orléans University Hospital and in compliance with Good Clinical Practices as well as the applicable legislative and regulatory provisions.
Participants will be fully and honestly informed, in understandable terms, about the objectives and constraints of the study, the potential risks incurred, the necessary monitoring and safety measures, and their rights to refuse to participate in the study or to withdraw at any time.
All this information is provided in an information form given to the patient. The patient's written consent will be obtained by the investigator, a junior doctor, or a representative doctor before any procedure specific to the study.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
All participants present one or more food allergy(ies) followed at Orléans University Hospital and agree to participate in the TROPHAPRICK study.
If a potential patient attends a consultation without their native foods, the investigator will not include them in the study. However, they may participate in the study during a subsequent follow-up consultation with the investigator (if recruitment is still ongoing).
The duration of the inclusion period is maximum 30 months (upon inclusion of the 100th patient) Each participant follow-up duration is 30 minutes (maximum 1 hour) The total research duration is 30 months maximum. The end of the study is defined as the date of the last visit of the last patient.
DIAGNOSTIC
NONE
Study Groups
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Food allergies arm
The participants are their own control. Performing all tests in a single session avoid analysis biases related to intra-individual variability in reactivity encountered during prick-tests performed on various dates (patient included only once in the study, no possible re-inclusion).
Prick-test
Several foods may be tested for the same participant depending on the number of food allergies the patient has. PT are performed using the "prick-to-prick" method with lancets, in a single session per patient, using fresh and preserved native foods. Simultaneously, a positive control and a negative control are performed. The PT are performed and read by nursing or medical staff trained in the technique.
Participants' clinical follow-up is performed continuously for 30 minutes from the performance of the prick-tests and under the responsibility of the allergologist doctor, whose presence is mandatory during the performance of these tests.
For meat, fruit, vegetable, leguminous plant, milk, seafood and fish tests will be performed with fresh products and with products preserved for 3 months as well as with products preserved for 6 months \[-15 days; +15 days\].
For dry foods (nuts and peanuts), tests will be performed with products harvested over 3 separate and consecutive seasons.
Interventions
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Prick-test
Several foods may be tested for the same participant depending on the number of food allergies the patient has. PT are performed using the "prick-to-prick" method with lancets, in a single session per patient, using fresh and preserved native foods. Simultaneously, a positive control and a negative control are performed. The PT are performed and read by nursing or medical staff trained in the technique.
Participants' clinical follow-up is performed continuously for 30 minutes from the performance of the prick-tests and under the responsibility of the allergologist doctor, whose presence is mandatory during the performance of these tests.
For meat, fruit, vegetable, leguminous plant, milk, seafood and fish tests will be performed with fresh products and with products preserved for 3 months as well as with products preserved for 6 months \[-15 days; +15 days\].
For dry foods (nuts and peanuts), tests will be performed with products harvested over 3 separate and consecutive seasons.
Eligibility Criteria
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Inclusion Criteria
2. Having a diagnosis of food allergy(ies) due to one or more of the food allergen studied, previously made by an allergologist, of grade 2 to 3 according to the Ring and Messmer classification.
3. Having given consent to participate in the study.
The diagnosis is made by the allergologist of the department due to the presence of a compatible clinical history implicating the tested allergen, the presence of evidence of sensitization to the allergen (positive prick-test and/or positive specific IgE assays), or even a positive oral allergen reintroduction test.
Exclusion Criteria
2. Hospitalization for asthma in the past 3 months
3. History of grade 4 anaphylactic reaction according to the Ring and Messmer classification.
4. Systemic antihistamine treatment in the 7 days preceding the test
5. Systemic beta-blocker treatment on the day of the test.
6. Protected person (under guardianship or curatorship)
7. Person under judicial supervision
8. Persons deprived of liberty
9. Person not affiliated with a social security insurance
10. Pregnant or breastfeeding women
18 Years
ALL
No
Sponsors
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Centre Hospitalier Régional d'Orléans
OTHER
Responsible Party
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Locations
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Centre Hospitalier Universitaire d'Orléans
Orléans, , France
Countries
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Central Contacts
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Facility Contacts
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Minaxi Dr PATEL, PhD
Role: primary
Julien Dr Lefrançois, PhD
Role: backup
References
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Other Identifiers
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CHUO-2024-19
Identifier Type: -
Identifier Source: org_study_id