Observational Study of IgE-Mediated Leguminous Allergies in a Pediatric Population

NCT07811141 | Not Yet Recruiting

• 1 other identifier: 2024_0445
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective, monocentric, observational study with standard care follow-up during 5 years or until the patient reaches the age of 18. The aim of this study is to prospectively and comprehensively assess the characteristics of patients aged 6 months to 17 years with leguminous allergy (excluding peanut) and their reactions to leguminous, including both medical history and prospective follow-up for 5 years from inclusion, or until the age of 18. The study aims to improve the understanding of these allergies, provide epidemiological data, and optimize diagnostic and clinical management. A biobank will also be established, with plasma (one whole blood sample collected at the inclusion) in order to validate future diagnostic tests.

Conditions

Hypersensitivity, Food; Legumes Allergy

Keywords

food hypersensitivity; allergy; fabaceae; leguminous; biobank

Outcome Measures

Primary Outcomes (1)

• Prospectively study, among the leguminous, the type of leguminous (excluding peanut) responsible for the allergy.

  The primary endpoint will be the number of allergy diagnoses for each type of leguminous (excluding peanut), among : * Green peas * Split peas (dried green peas) * Yellow or blond dried peas * Chickpeas * Green, red, or blond lentils * Green, Kidney, White or Mung beans * Soybean * Lupin * Fenugreek * Fava bean (broad bean) * Beluga lentils * Black-eyed peas (cowpeas), adzuki beans,and urad beans * Alfalfa

  Baseline (Inclusion) 1 Year from the Inclusion 5 years from the inclusion, or until the age of 18

Secondary Outcomes (12)

• Describe the age at onset and severity of the first manifestation

  Baseline (Inclusion)

• Describe quality of life (FAQLQ questionnaires) in children aged 8 years or older

  Baseline (Inclusion)

• Establish a biobank (blood - plasma samples) to validate future diagnostic tests

  Baseline (Inclusion)

• Describe the severity of reactions by legume (FASS score)

  Baseline (Inclusion) 1 Year from the Inclusion 5 years from the inclusion, or until the age of 18

• Describe the frequency of anaphylaxis by legume (according to the WAO definition)

  Baseline (Inclusion) 1 Year from the Inclusion 5 years from the inclusion, or until the age of 18

Eligibility Criteria

• Age: 6 Months - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Cohort of patients with the disease (leguminous allergy), between 6 months to 17 years old, with medical follow up in Pneumo-allergy unit - CHU Lille

You may qualify if:

• Subjects aged 6 months to 17 years old
• Medical diagnosis of allergy to one or more leguminous :
• Clinical reaction following real-life exposure AND positive skin and/or biological sensitization
• Allergy confirmed by a positive oral food challenge (OFC) in cases of sensitization without a history of clinical reaction
• Subjects seen in a pediatric pneumo-allergy unit (consultation or hospitalization)

You may not qualify if:

• Isolated IgE-mediated peanut allergy
• Patients aged 18 years or older
• Minor patient or legal representant (parental authority) Refusal

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

CHU Lille

Lille, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma (whole blood on EDTA Tube)

MeSH Terms

Conditions

Food Hypersensitivity; Hypersensitivity

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Immune System Diseases

Central Study Contacts

Celine CLAIRET-LESPINASSE

CONTACT

+33 3204441145; celine.clairet@chu-lille.fr

DRS. Promotion

CONTACT

+33 3204441145; drs.promotion@chu-lille.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2026
• First Posted: September 9, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): September 1, 2034
• Study Completion (Estimated): September 1, 2034
• Last Updated: October 1, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)