Hypersensitivity, Food, Legumes Allergy
Conditions
Keywords
food hypersensitivity, allergy, fabaceae, leguminous, biobank
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.
Interventions
None listed
Sponsors
University Hospital, Lille
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Months to 17 Years
Healthy volunteers
No
Inclusion criteria
* 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)
Exclusion criteria
* Isolated IgE-mediated peanut allergy * Patients aged 18 years or older * Minor patient or legal representant (parental authority) Refusal
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prospectively study, among the leguminous, the type of leguminous (excluding peanut) responsible for the allergy. | Baseline (Inclusion) 1 Year from the Inclusion 5 years from the inclusion, or until the age of 18 | 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 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Describe the frequency of severe anaphylaxis by legume (FASS-5 Grades 4 and 5) | Baseline (Inclusion) 1 Year from the Inclusion 5 years from the inclusion, or until the age of 18 |
| Describe associations between allergies to different leguminous. | Baseline (Inclusion) 1 Year from the Inclusion 5 years from the inclusion, or until the age of 18 |
| Describe allergic comorbidities (asthma, rhinitis, atopic dermatitis, and pollinosis) | Baseline (Inclusion) 1 Year from the Inclusion 5 years from the inclusion, or until the age of 18 |
| Describe associated food allergies, including peanut and other foods | Baseline (Inclusion) 1 Year from the Inclusion 5 years from the inclusion, or until the age of 18 |
| Describe allergy management strategies: targeted avoidance, broad avoidance, emergency kit with an adrenaline auto-injector, and school-based management (Individualized Healthcare Plan) | Baseline (Inclusion) 1 Year from the Inclusion 5 years from the inclusion, or until the age of 18 |
| Assess parents' knowledge of the different leguminous | Baseline (Inclusion) 1 Year from the Inclusion 5 years from the inclusion, or until the age of 18 |
| Prospectively assess allergic reactions in real-life settings: number of reactions, severity, type of food (prepackaged ready-made meal or homemade meal), labeling, quantity consumed, location of occurrence, and management | Baseline (Inclusion) 1 Year from the Inclusion 5 years from the inclusion, or until the age of 18 |
Countries
France
Contacts
CONTACTCeline CLAIRET-LESPINASSE
CONTACTDRS. Promotion
Outcome results
None listed