Food AllergyGIBBERELLINESNCT06183398
Analysis of the Prevalence of Sensitization to Plants Containing Gibberellins Using Realistic Skin Prick Tests
A study testing Skin prick test in people with Food Allergy, run by University Hospital, Montpellier at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Food Allergy
- What is being tested?
- Skin prick test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteFrance
- Study dates
- 14 Mar 2024to 14 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
University Hospital of Montpellier
Montpellier, 34295
Davide CAIMMI, MD, +33467336112, dp-caimmi@chu-montpellier.fr
About this study
Official 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.
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%).
Read more
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
- Being tested
- Skin prick test
- Keywords
- Gibberellins, prevalence, sensitization, Pru p 7, cross-reactions
- Medical subject headings
- Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin prick testOther
Specific skin prick tests for 6 raw food: peach, apple, sesame, carrot, lemon and orange
| Study group | Role | What they receive |
|---|---|---|
| Eligible patients | Experimental | Not described Receives: Other: Skin prick test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 1 day
Prevalence of IgE positivity to GRP Pru p 7 in patients sensitized to cypress pollen and at least one food containing GRPs
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.
Measured: 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
Percentage of patients sensitized and symptomatic to peach, apple, sesame, carrot, lemon and orange and to cypress pollen
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2023
- Study start14 Mar 2024
- Primary completion14 Mar 2028 (estimated)
- Study completion14 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food AllergyStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Davide CAIMMI, MD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06183398
- Sponsor's protocol ID
- RECHMPL22_0516
- Other IDs
- 2023-A01737-38
- Acronym
- GIBBERELLINES
- Status last verified
- Sep 2025
- First submitted
- 13 Dec 2023
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT06183398
- Acronym / sponsor ID
- GIBBERELLINES / RECHMPL22_0516
- Conditions
- Food Allergy
- Keywords
- Gibberellins, prevalence, sensitization, Pru p 7, cross-reactions
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 14 Mar 2024 (actual)
- Primary completion
- 14 Mar 2028 (estimated)
- Study completion
- 14 Mar 2028 (estimated)
- First posted
- 27 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eligible patients | Experimental | Other: Skin prick test |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skin prick testSpecific skin prick tests for 6 raw food: peach, apple, sesame, carrot, lemon and orange | Other | Eligible patients |
Primary outcome
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.
3 secondary outcomes
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Davide CAIMMI, MD principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skin prick test in people with Food Allergy, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Davide CAIMMI, MD (+33467336112, dp-caimmi@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025.