NCT06183398 Analysis of the Prevalence of Sensitization to Plants Containing Gibberellins Using Realistic Skin Prick Tests
| NCT ID | NCT06183398 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Montpellier |
| Condition | Food Allergy |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,000 participants |
| Start Date | 2024-03-14 |
| Primary Completion | 2028-03-14 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 2,000 participants in total. It began in 2024-03-14 with a primary completion date of 2028-03-14.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Davide CAIMMI, MD
PRINCIPAL INVESTIGATOR
University Hospital, Montpellier
Frequently Asked Questions
Who can join the NCT06183398 clinical trial?
This trial is open to participants of all sexes, aged 5 Years or older, studying Food Allergy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06183398 currently recruiting?
Yes, NCT06183398 is actively recruiting participants. Contact the research team at dp-caimmi@chu-montpellier.fr for enrollment information.
Where is the NCT06183398 trial being conducted?
This trial is being conducted at Montpellier, France.
Who is sponsoring the NCT06183398 clinical trial?
NCT06183398 is sponsored by University Hospital, Montpellier. The principal investigator is Davide CAIMMI, MD at University Hospital, Montpellier. The trial plans to enroll 2,000 participants.