Analysis of the Prevalence of Sensitization to Plants Containing Gibberellins Using Realistic Skin Prick Tests

NCT ID: NCT06183398

Last Updated: 2025-10-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 2000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-14
• Study Completion Date: 2028-03-14

Brief Summary

Gibberellin-related proteins (GRPs) are proteins contained in both pollens and vegetables and are associated with an increased risk of severe food allergy reactions. The best characterized one the only one for which a specific IgE (Immunoglobulin E) may be dosed in current clinical practice is Pru p 7, an allergen contained in peaches (Prunus persica). Sensitization to GRPs seems to be greater in areas with high exposure to pollens of the Cupressaceae family (as in the Montpellier region in Southern France); a subtype of Cupressaceae pollinosis, characterized by sensitization to Pru p 7 has been shown to be responsible for severe peach allergies.

To date, there has been no real analysis of the prevalence of sensitization to GRPs, or of possible cross-sensitization between plants and foods containing GRPs. Main food containing GRPs with a high level of homology with Pru p 7 include apples (Malus domestica, 97.3%), sesame (Sesamum indicum, 91.9%), carrots (Daucus carota subsp. Sativus, 88.9%), lemons and oranges (different species, with a homology of 87.3%).

If investigators consider that sensitization to GRPs could be associated with severe allergic hypersensitivity reactions, it is important to detect the prevalence of sensitization to these allergens and to find sensitization profiles for these patients in order to gain a better understanding of this type of allergy and offer a more appropriate and preventive management to allergic patients. This remains today a major challenge for the allergy community in the Mediterranean region.

This study aims to investigate the rate of sensitization to peach and 5 other allergens containing gibberellins, chosen on the basis of their homology with Pru p 7 (the gibberellin from Prunus persica): carrot, lemon, orange, apple and sesame.

Conditions

Food Allergy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Eligible patients

Group Type: EXPERIMENTAL

Skin prick test

Intervention Type: OTHER

Specific skin prick tests for 6 raw food: peach, apple, sesame, carrot, lemon and orange

Interventions

Skin prick test

Specific skin prick tests for 6 raw food: peach, apple, sesame, carrot, lemon and orange

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients aged at least 5 years
• Patients consulting at the Allergy Unit of the University Hospital of Montpellier for any type of allergy work-up/evaluation
• Oral consent from the patient and, where applicable, from at least one of the patient's legal representatives in the case of minors.

Exclusion Criteria

• Patients treated with antihistamines or psychotropic drugs with antihistaminic action during the 7 days prior to inclusion
• Patients with pathologies that prevent the performance of prick tests (e.g. severe peripheral neuropathy, cutaneous anergy).
• Patients with dermographism.
• Patient taking part in another study which may influence the results of the prick tests.
• Patients in an exclusion period determined by a previous study.
• Pregnant, parturient or breast-feeding women.
• Patients or their legal representatives under court protection, guardianship or trusteeship.
• Patients or their legal representatives who are not members or beneficiaries of a health insurance scheme.
• Patient or his/her legal representative unable to read and understand French fluently.

• Minimum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Davide CAIMMI, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Montpellier

Locations

University Hospital of Montpellier

Montpellier, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Davide CAIMMI, MD

Role: CONTACT

dp-caimmi@chu-montpellier.fr

+33467336112

Facility Contacts

Davide CAIMMI, MD

Role: primary

dp-caimmi@chu-montpellier.fr

+33467336112

Other Identifiers

2023-A01737-38

Identifier Type: REGISTRY

Identifier Source: secondary_id

RECHMPL22_0516

Identifier Type: -

Identifier Source: org_study_id