Hypersensitivity, FoodFabALLNCT07811141
Observational Study of IgE-Mediated Leguminous Allergies in a Pediatric Population
An observational study of Hypersensitivity, Food and Legumes Allergy, run by University Hospital, Lille at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 months to 17 years
- Conditions the study is for
- Hypersensitivity, Food, Legumes Allergy
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2026to Nov 2034
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 17 years
- All sexes
- No healthy volunteers
- Child
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
Who may be able to join
- 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)
Who cannot join
- Isolated IgE-mediated peanut allergy
- Patients aged 18 years or older
- Minor patient or legal representant (parental authority) Refusal
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
CHU Lille
Lille
Celine CLAIRET-LESPINASSE, +33320444145, celine.clairet@chu-lille.fr
Marie MOYART, Doctor
About this study
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
- Medical subject headings
- Food Hypersensitivity, Hypersensitivity
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: Baseline (Inclusion)
Establish a biobank (blood - plasma samples) to validate future diagnostic tests
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: Baseline (Inclusion) 1 Year from the Inclusion 5 years from the inclusion, or until the age of 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study startNov 2026 (estimated)
- Primary completionNov 2034 (estimated)
- Study completionNov 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypersensitivity, FoodStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07811141
- Sponsor's protocol ID
- 2024_0445
- Acronym
- FabALL
- Status last verified
- Nov 2026
- First submitted
- 2 Sep 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of IgE-Mediated Leguminous Allergies in a Pediatric Population
- ClinicalTrials.gov ID
- NCT07811141
- Acronym / sponsor ID
- FabALL / 2024_0445
- Conditions
- Hypersensitivity, Food, Legumes Allergy
- Keywords
- food hypersensitivity, allergy, fabaceae, leguminous, biobank
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Nov 2034 (estimated)
- Study completion
- Nov 2034 (estimated)
- First posted
- 9 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (3 listed)
- Isolated IgE-mediated peanut allergy
- Patients aged 18 years or older
- Minor patient or legal representant (parental authority) Refusal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prospectively study, among the leguminous, the type of leguminous (excluding peanut) responsible for the allergy.
Time frame: 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
12 secondary outcomes
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
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)
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypersensitivity, Food and Legumes Allergy, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Celine CLAIRET-LESPINASSE (+33 3204441145, celine.clairet@chu-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prospectively study, among the leguminous, the type of leguminous (excluding peanut) responsible for the allergy. (time frame: Baseline (Inclusion) 1 Year from the Inclusion 5 years from the inclusion, or until the age of 18). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.