- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02966938
Visual Recognition of Allergens by Allergic Patients and/or Their Parents (REVIALL)
Food allergies are constantly increasing. Peanut and nut allergies are a major cause of allergic reactions. Diagnosed patients are also at risk, because 27% of the patients that had an allergic reaction have another one in the following year with the same food, despite a real improvement in industrial products labeling.
The investigators have observed in the allergy Unit that patients (and/or their family) following an elimination diet, sometimes since several years, use very strict elimination strategies. Those strategies sometimes lead to incapacities to recognize the allergens. Yet, a good identification of the allergen is the key to a successful elimination and the non-identification a known risk factor.
Ferdman shown in 2006 that 27% of the patients didn't recognize the allergen there were allergic to. However, this is a US study, and geographical specificities have an impact on food consumption and culture. Food allergology needs to take those two elements into account. For example, in France, a single food can have two names. It is the case of peanut, which can be called "arachide", or more frequently "cacahuète".
The goal of the study is to observe patient aptitudes to recognize peanut (and the association between the two names) and other nuts available in France and define by the European law, using a plate with various food samples in seed or in shell.
Thus, patients in care at the allergy Unit of Saint Vincent Hospital of Lille (France) and their families were surveyed with a standardized procedure at the beginning of their therapeutic education and their capacity to recognize various nuts, to identify peanut ("cacahuète" or "arachide") and to associate the two words "cacahuète" and "arachide" was assessed. It is a standard procedure in therapeutic education, and the responses have been systematically entered in the medical record.
The main objective of this study is to describe peanut or nut allergic patient capacity (adult, children and/or the family) to visually identify the foods there are allergic to.
The secondary objective of this study is to describe the capacity of patient that describe themselves as allergic to "arachide" to associate this word to the word "cacahuète".
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Peanut or nut allergy
- Following an elimination diet since at least 3 months
- Results obtained at the beginning of a therapeutic education started from 2013 to 2015
Exclusion Criteria:
- Patients opposed to enter the study
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Nut allergic patients
Allergic patient and their family with allergy to peanut or other tree nuts that are in elimination diet.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of patient that can visually identify the foods there are allergic to.
Time Frame: At inclusion
|
At inclusion
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
number of patients presenting themselves as allergic to "arachide" knowing it is a synonym of "cacahuète"
Time Frame: at inclusion
|
at inclusion
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Christine Sauvage, MD, GHICL
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OBS-048
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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