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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02966938
Other study ID # OBS-048
Secondary ID
Status Completed
Phase N/A
First received November 15, 2016
Last updated November 17, 2016
Start date December 2015
Est. completion date March 2016

Study information

Verified date November 2016
Source Lille Catholic University
Contact n/a
Is FDA regulated No
Health authority France: Ministry of Health
Study type Observational

Clinical Trial Summary

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".


Recruitment information / eligibility

Status Completed
Enrollment 440
Est. completion date March 2016
Est. primary completion date March 2016
Accepts healthy volunteers No
Gender Both
Age group 3 Years and older
Eligibility 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 Design

Observational Model: Case-Only, Time Perspective: Retrospective


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Lille Catholic University

Outcome

Type Measure Description Time frame Safety issue
Primary Number of patient that can visually identify the foods there are allergic to. At inclusion No
Secondary number of patients presenting themselves as allergic to "arachide" knowing it is a synonym of "cacahuète" at inclusion No
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