Allergic ReactionPEC-ALLNCT05185362
Epidemiology of Pecan Nut Allergy
An observational study of Allergic Reaction, run by University Hospital, Montpellier at 1 site in France.
Trial summary
IgE-mediated food allergy can manifest with reactions ranging from hives to anaphylactic shock. The diagnosis is based on the confirmation of sensitization to the food allergen by skin tests (prick) and the determination of specific IgE directed against the food source and molecular allergens. Read more about this study
- Who is it for?
- Ages 5 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Allergic Reaction
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2021to 1 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients consulting in the Allergy Unit of the Arnaud de Villeneuve Hospital, sensitized to pecan nut, and having undergone an oral food challenge to this food allergen
Who may be able to join
- Patients assessed for pecan allergy, through oral food challenge, from January 2000 to december 2021, at the University Hospital of Montpellier
- Patients with a positive skin prick test and/or positive specific IgE to pecan nut
Who cannot join
- Patients not affiliated to French Social Security
- Patients not capable of understanding French
- Patients sensitized to pecan nut, who did not perform an oral food challenge to this food allergen
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Uhmontpellier
Montpellier, 34295
Davide CAIMMI, MD, 467336112 ext. 33, davide.caimmi@gmail.com
About this study
Official title: Retrospective Study on Pecan Nut Allergy Epidemiology
IgE-mediated food allergy can manifest with reactions ranging from hives to anaphylactic shock. The diagnosis is based on the confirmation of sensitization to the food allergen by skin tests (prick) and the determination of specific IgE directed against the food source and molecular allergens. The gold standard remains the oral provocation test, which is performed in a hospital environment. Once the diagnosis is made, an elimination diet is still considered as the cornerstone of treatment for most food allergies.
While some allergies, such as cow's milk or egg, tend to resolve spontaneously, others, such as allergy to pecan nuts, show a tendency to be persistent. In addition, pecan allergy is often characterized by potentially serious clinical reactions, compared to other foods, which can even be life threatening. In our clinical practice, the investigators found that patients with allergies to pecan nuts often present with severe hypersensitivity reactions when challenged orally to this food. Beyond this information, there are few studies regarding pecans. The investigators decided to retrospectively evaluate the results of oral food challenge and of the allergy work-up in our patients sensitized and allergic to pecan nuts, to better understand the current epidemiology of such food allergy.
- Conditions
- Allergic Reaction
- Keywords
- Sensitization to pecan nut (specific IgE and/or skin prick tests), Challenge proven pecan allergy, Allergic Comorbidities, Oral food challenge, Anaphylaxis
- Medical subject headings
- Hypersensitivity, Anaphylaxis
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of challenge-proven pecan allergy
Prevalence of challenge-proven pecan allergy in sensitized patients
Measured: day 1
Secondary outcomes (2)
Epidemiological characteristics of pecan allergic patient
Epidemiological characteristics of pecan allergic patient(cypress pollen-induced allergic rhinitis or food allergy to peach)
Measured: day 1
cut-off of specific IgE
cut-off of specific IgE and of results of prick test to predict pecan allergy in sensitized and allergic patients
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start1 Nov 2021
- Primary completion1 Jan 2022 (estimated)
- Study completion1 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic ReactionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Davide CAIMMI, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05185362
- Sponsor's protocol ID
- RECHMPL21_0726
- Acronym
- PEC-ALL
- Status last verified
- Dec 2021
- First submitted
- 22 Dec 2021
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study on Pecan Nut Allergy Epidemiology
- ClinicalTrials.gov ID
- NCT05185362
- Acronym / sponsor ID
- PEC-ALL / RECHMPL21_0726
- Conditions
- Allergic Reaction
- Keywords
- Sensitization to pecan nut (specific IgE and/or skin prick tests), Challenge proven pecan allergy, Allergic Comorbidities, Oral food challenge, Anaphylaxis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 1 Apr 2022 (estimated)
- First posted
- 11 Jan 2022 (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.
IgE-mediated food allergy can manifest with reactions ranging from hives to anaphylactic shock. The diagnosis is based on the confirmation of sensitization to the food allergen by skin tests (prick) and the determination of specific IgE directed against the food source and molecular allergens. The gold standard remains the oral provocation test, which is performed in a hospital environment. Once the diagnosis is made, an elimination diet is still considered as the cornerstone of treatment for most food allergies.
While some allergies, such as cow's milk or egg, tend to resolve spontaneously, others, such as allergy to pecan nuts, show a tendency to be persistent. In addition, pecan allergy is often characterized by potentially serious clinical reactions, compared to other foods, which can even be life threatening. In our clinical practice, the investigators found that patients with allergies to pecan nuts often present with severe hypersensitivity reactions when challenged orally to this food. Beyond this information, there are few studies regarding pecans. The investigators decided to retrospectively evaluate the results of oral food challenge and of the allergy work-up in our patients sensitized and allergic to pecan nuts, to better understand the current epidemiology of such food allergy.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 5 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients consulting in the Allergy Unit of the Arnaud de Villeneuve Hospital, sensitized to pecan nut, and having undergone an oral food challenge to this food allergen
Key inclusion criteria (2 listed)
- Patients assessed for pecan allergy, through oral food challenge, from January 2000 to december 2021, at the University Hospital of Montpellier
- Patients with a positive skin prick test and/or positive specific IgE to pecan nut
Key exclusion criteria (3 listed)
- Patients not affiliated to French Social Security
- Patients not capable of understanding French
- Patients sensitized to pecan nut, who did not perform an oral food challenge to this food allergen
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of challenge-proven pecan allergy
Time frame: day 1
Prevalence of challenge-proven pecan allergy in sensitized patients
2 secondary outcomes
Epidemiological characteristics of pecan allergic patient
Time frame: day 1
cut-off of specific IgE
Time frame: day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
- Individual participant dataSharing planned: Undecided. NC
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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. This study is not recruiting at the moment.
Davide CAIMMI study director
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allergic Reaction, 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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 11 Jan 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Davide CAIMMI, MD (467336112 ext. 33, davide.caimmi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of challenge-proven pecan allergy (time frame: day 1). 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 11 Jan 2022; AzTrials last refreshed its copy on 6 Nov 2026.