Observational Study of IgE-Mediated Leguminous Allergies in a Pediatric Population
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-17
SponsorUniversity Hospital, Lille
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subjects aged 6 months to 17 years old
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)
Disqualifiers
Isolated IgE-mediated peanut allergy
Patients aged 18 years or older
Minor patient or legal representant (parental authority) Refusal
Trial 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
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
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
Time frame
Baseline (Inclusion) 1 Year from the Inclusion 5 years from the inclusion, or until the age of 18Secondary outcomes
1
Describe the age at onset and severity of the first manifestation
Time frame
Baseline (Inclusion)2
Describe quality of life (FAQLQ questionnaires) in children aged 8 years or older
Food Allergy Quality of Life Questionnaire : several forms tailored to the patient's age or intended for family members: * FAQLQ-PF (Parent Form): for parents of children aged 0 to 12; * FAQLQ-CF (Child Form): for children aged 8 to 12; * FAQLQ-TF (Teenager Form): for adolescents; * FAQLQ-PTF (for parents of adolescents). Each item is rated on a scale of 1 to 7 (Minimum Value = 1 and Maximum Value =7). Depending on the specific FAQLQ instrument used, the number of items varies, resulting in different minimum and maximum total scores : * FAQLQ-CF: Total score ranges from 24 to 204 * FAQLQ-TF: Total score ranges from 29 to 203 * FAQLQ-PF: Total score ranges from 0 to 180 * FAQLQ-PTF: Total score ranges from 0 to 186 Higher scores indicate a worse outcome.
Time frame
Baseline (Inclusion)3
Establish a biobank (blood - plasma samples) to validate future diagnostic tests
Time frame
Baseline (Inclusion)4
Describe the severity of reactions by legume (FASS score)
Title: Food Allergy Severity Score. Scores range from a minimum of 1 (representing a mild allergic reaction) to a maximum of 5 (representing a very severe allergic reaction). Higher scores indicate a worse outcome.
Time frame
Baseline (Inclusion) 1 Year from the Inclusion 5 years from the inclusion, or until the age of 18Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: