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Not yet recruitingNCT07811141FabALLUpdated Sep 9, 2026

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

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 2026-09-09.

Sponsored by University Hospital, Lille · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
6 Months to 17 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Hypersensitivity, Food
  • Legumes Allergy

Keywords

  • food hypersensitivity
  • allergy
  • fabaceae
  • leguminous
  • biobank
03

Who can participate

Ages eligible
6 Months to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No
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

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

Exclusion Criteria:

  • Isolated IgE-mediated peanut allergy
  • Patients aged 18 years or older
  • Minor patient or legal representant (parental authority) Refusal
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna
05

What researchers measure

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 18

Secondary 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

    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)

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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

06

Study locations

1 site
  • CHU Lille
    Lille, France
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07811141
Lead sponsor
University Hospital, Lille
Responsible party
Sponsor
First posted
Sep 9, 2026
Start date
Sep 2026 (estimated)
Primary completion
Sep 2034 (estimated)
Completion
Sep 2034 (estimated)
Last update
Sep 9, 2026

Study contacts

Celine CLAIRET-LESPINASSE
Contact
celine.clairet@chu-lille.fr
+33 3204441145
DRS. Promotion
Contact
drs.promotion@chu-lille.fr
+33 3204441145

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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