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

Sensitization to Legumes Clinical Trial

— Légumineuses  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03686891
• Other study ID #: 9776
• Status: Completed
• Phase: N/A
• Start date: January 24, 2018
• Est. completion date: September 16, 2022

Study information

• Verified date: October 2022
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2000
• Est. completion date: September 16, 2022
• Est. primary completion date: September 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sensitization to Legumes

Intervention

Other:
• Skin prick tests with four native legumes
Skin prick tests with four native legumes

Locations

Country	Name	City	State
France	Service Exploration des allergologies-Hopital Arnaud de Villeneuve-CHU de Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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