An observational study in Hypersensitivity, Food and Legumes Allergy, sponsored by University Hospital, Lille. Not yet recruiting at 1 site in France. Open to participants aged 6 Months to 17 Years. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by University Hospital, Lille · Observational
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.
376 studies on the registry are indexed under Food Hypersensitivity; 90 are open to participants now.
This study's planned enrollment of 100 is below the median of 151 across 120 observational studies indexed under Food Hypersensitivity.
Browse Food Hypersensitivity studies →University Hospital, Lille is the lead sponsor of 631 studies on the registry; 142 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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 18
Describe the age at onset and severity of the first manifestation
Time frame: Baseline (Inclusion)
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)
Establish a biobank (blood - plasma samples) to validate future diagnostic tests
Time frame: Baseline (Inclusion)
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 18
Describe the frequency of anaphylaxis by legume (according to the WAO definition)
Time frame: 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)
Time frame: 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.
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: Baseline (Inclusion) 1 Year from the Inclusion 5 years from the inclusion, or until the age of 18
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.