NCT05185362

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 22, 2021

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 11, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

January 11, 2022

Status Verified

December 1, 2021

Enrollment Period

2 months

First QC Date

December 22, 2021

Last Update Submit

December 22, 2021

Conditions

Keywords

Sensitization to pecan nut (specific IgE and/or skin prick tests)Challenge proven pecan allergyAllergic ComorbiditiesOral food challengeAnaphylaxis

Outcome Measures

Primary Outcomes (1)

  • Prevalence of challenge-proven pecan allergy

    Prevalence of challenge-proven pecan allergy in sensitized patients

    day 1

Secondary Outcomes (2)

  • Epidemiological characteristics of pecan allergic patient

    day 1

  • cut-off of specific IgE

    day 1

Eligibility Criteria

Age5 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

RECRUITING

MeSH Terms

Conditions

HypersensitivityAnaphylaxis

Condition Hierarchy (Ancestors)

Immune System DiseasesHypersensitivity, Immediate

Study Officials

  • Davide CAIMMI

    University Hospital, Montpellier

    STUDY DIRECTOR

Central Study Contacts

Davide CAIMMI, MD

CONTACT

Audrey GOPAL, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2021

First Posted

January 11, 2022

Study Start

November 1, 2021

Primary Completion

January 1, 2022

Study Completion

April 1, 2022

Last Updated

January 11, 2022

Record last verified: 2021-12

Locations