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

NCT06183398 | Recruiting

• 2 other identifiers: RECHMPL22_05162023-A01737-38
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 1

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

Keywords

Gibberellins; prevalence; sensitization; Pru p 7; cross-reactions

Outcome Measures

Primary Outcomes (1)

• Prevalence of sensitization to six GRPs-containing foods (peach, carrot, lemon, orange, apple, sesame) in the population of patients consulting at the Allergy Unit of the University Hospital of Montpellier

  Percentage of patients sensitized to peach, apple, sesame, carrot, lemon and orange. Sensitization to each food allergen tested is defined by the presence of an urticarial papule at least 3 mm long on the skin after skin prick test.

  1 day

Secondary Outcomes (3)

• Prevalence of patients sensitized to cypress pollen and to six GRPs-containing foods (peach, carrot, lemon, orange, apple, sesame) in the population of patients consulting at the Allergy Unit of the University Hospital of Montpellier

  1 day

• Prevalence of IgE positivity to GRP Pru p 7 in patients sensitized to cypress pollen and at least one food containing GRPs

  1 day

• Correlation between sensitization to any of the six GRPs-containing foods (peach, carrot, lemon, orange, apple, sesame) and presented symptoms to any of these food and to sensitization to cypress pollen

  1 day

Study Arms (1)

Eligible patients

EXPERIMENTAL

Other: Skin prick test

Interventions

Skin prick test OTHER

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

Eligible patients

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

University Hospital of Montpellier

Montpellier, 34295, France

RECRUITING

MeSH Terms

Conditions

Food Hypersensitivity

Interventions

Patch Tests

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Skin Tests; Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques

Study Officials

• Davide CAIMMI, MD

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Davide CAIMMI, MD

CONTACT

+33467336112; dp-caimmi@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2023
• First Posted: December 27, 2023
• Study Start: March 14, 2024
• Primary Completion (Estimated): March 14, 2028
• Study Completion (Estimated): March 14, 2028
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)