Prevalence of Sensitization to Legumes in a Region From Southern France (Légumineuses) (Légumineuses)

Analyis of the Prevalence of Sensitization to Legumes by Realistic Skin Prick Tests in a Patient Population Consulting at the University Hospital of Montpellier

The Mediterranean diet is a model for health. Indeed, according to some epidemiological studies, it would participate in the prevention of various diseases such as cardiovascular diseases, diabetes type 2, cancer and obesity. Among the foods composing the Mediterranean diet, wheat and legumes are strongly represented. The introduction of legumes into an easily prepared and economical food for a large part of the population will lead to an increase in consumption. The combination of durum wheat semolina and legume flour would benefit from the nutritional qualities of the two raw materials (high protein, slow digestible carbohydrates, fiber, vitamins and minerals), but also of their double wheat-legume allergenicity.

Study Overview

• Status: Completed
• Conditions: Sensitization to Legumes
• Intervention / Treatment: Other: Skin prick tests with four native legumes

• Study Type: Interventional
• Enrollment (Actual): 2000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • Service Exploration des allergologies-Hopital Arnaud de Villeneuve-CHU de Montpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients seen in allergy consultation
• The patient (or parents for the under 18 years) must have given their free consent and signed the consent chart
• Men and women are included
• The patient is at least 2 years old

Exclusion Criteria:

• The patient is pregnant
• The patient is breast-feeding
• The patient is unable to stop in antihistamine medication for at least 7 days
• The patient refused or is unable to sign the consent chart
• The patient has a dermographism

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; Skin prick tests with four native legumes	Other: Skin prick tests with four native legumes; Skin prick tests with four native legumes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitization rate to four cooked legumes in the population consulting in Allergy Unit at the University Hospital of Montpellier	A prick test will be considered as positive in the presence of a wheal of urticaria of at least 3 mm in size	10 minutes (the average duration of the test will not be significantly increased)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Describe the population with positive skin prick tests to legumes	A prick test will be considered as positive in the presence of a wheal of urticaria of at least 3 mm in size	5 years
Associations between symptoms on ingestion of these legumes	Association between the positivity of the legume prick test and (1) symptoms upon ingestion of legumes (e.g., aracid and other fruits and vegetables), (2) symptoms of rhinitis, asthma, atopic eczema, and (3) positivity to other prick tests of the standard pneumallergen battery	5 years

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2018
• Primary Completion (Actual): September 16, 2022
• Study Completion (Actual): September 16, 2022

Study Registration Dates

• First Submitted: September 25, 2018
• First Submitted That Met QC Criteria: September 25, 2018
• First Posted (Actual): September 27, 2018

Study Record Updates

• Last Update Posted (Actual): October 17, 2022
• Last Update Submitted That Met QC Criteria: October 14, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 9776

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No