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NCT Number: NCT06183398

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

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.

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Key information

Age range

5 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Montpellier

Montpellier, 34295, France

Location status: Recruiting

Location contact

Davide CAIMMI, MD

CONTACT

[email protected]

+33467336112

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Skin prick test

Other

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

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

    Time frame: 1 day

    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.

Secondary outcomes

  1. 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

    Time frame: 1 day

    Percentage of patients sensitized to cypress pollen associated with a sensitization 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.

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

    Time frame: 1 day

    Percentage of IgE positivity to GRP Pru p 7 in patients sensitized to cypress pollen associated with at least one food tested containing GRPs (peach, apple, sesame, carrot, lemon and orange) Immunoglobulin E (IgE) positivity will be measured with the ImmunoCAP® method and is defined as a specific IgE level > 0.10 kUnit/L.

  3. 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

    Time frame: 1 day

    Percentage of patients sensitized and symptomatic to peach, apple, sesame, carrot, lemon and orange and to cypress pollen

Study contacts

Contact information is provided by the study sponsor or research team.

Davide CAIMMI, MD

CONTACT

[email protected]

+33467336112

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

Analysis of the Prevalence of Sensitization to Plants Containing Gibberellins Using Realistic Skin Prick Tests in a Population of Patients Attending the Montpellier University Hospital.

Acronym: GIBBERELLINES

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Dec 27, 2023
Registry last updated
Oct 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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