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NCT Number: NCT07811141

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

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.

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Key information

Conditions

Hypersensitivity, Food Food Hypersensitivity Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Legumes Allergy

Age range

6 month–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Lille

Lille, France

Location contact

Celine CLAIRET-LESPINASSE

CONTACT

[email protected]

+33320444145

Marie MOYART, Doctor

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Celine CLAIRET-LESPINASSE

CONTACT

[email protected]

+33 3204441145

DRS. Promotion

CONTACT

[email protected]

+33 3204441145

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Acronym: FabALL

Important dates

Study start
2026
Primary completion
2034
Study completion
2034
First posted
Sep 9, 2026
Registry last updated
Sep 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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