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NCT Number: NCT06634992

Observatory of the Lille Paediatric Allergy Unit

The goal of this study is to set up a paediatric observatory within the allergology department of The saint Vincent Hospital, Lille. The study aims to:

• Collect exhaustive prospective data from patients eligible for oral immunotherapy.

This prospective observatory will enable statistical analyses to be carried out on common food allergens such as hazelnut, cashew nut, pistachio and others.

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Key information

Conditions

Child Allergy Food Allergy Food Hypersensitivity Hypersensitivity Hypersensitivity, Immediate IgE-Mediated Allergic Process Immune System Diseases

Age range

Up to 16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Groupement de l'Institut Catholique de Lille - Hôpital Saint Vincent de Paul

Lille, 59000, France

Location status: Recruiting

Location contact

Tomas MORALY

CONTACT

About this study

During the consultation, the allergist will inform the legal representative and the child about the terms of the study, and will provide them with an information note specifying the objectives of the study and its terms, the involvement of the child and his or her rights.

Depending on the allergen involved, the oral immunotherapy session will be assigned to one of three study groups: 1) allergen to hazelnut, walnut, pistachio, cashew or peanut,2) allergen to cow's milk, wheat or egg, 3) allergen to unusual foods: sesame, celery, fenugreek, peas, lentils, etc.

For each patient, and for each visit during the treatment period the collection of anthropometric, sociodemographic and medical data relating to oral food challenge will be done

Oral immunotherapy will then be started in accordance with standard practice. During this first visit, the investigator will give the patient a diary in which to record information about any IgE-mediated side-effects of the oral immunotherapy. Subsequent visits will follow the patient's usual routine until the desensitisation threshold is reached or the patient decides to stop the oral immunotherapy protocol. Visits will be made every 6 months, with a window of two months around each date.During these monitoring visits, tthe collection of anthropometric, sociodemographic and medical data relating to oral food challenge will be continue.

During each visit, a new food challenge test may be performed at the investigator's discretion to assess a new reactogenic threshold. Following this test, the following data will be collected:

  • the cumulative dose ingested (mg food and mg food protein)
  • the grade of the reaction (from 0 to 5 according to the Astier et Coll classification)
  • achievement of desensitisation

A patient begins oral immunotherapy following food challenge test in a day hospital. Thus, a patient consulting at different times for several allergies and eligible for several oral immunotherapies will be able to take part in the study for several allergens. The follow-up of the different oral immunotherapies started (maximum 2 simultaneously, but could go up to 5, 6... over time) will be distinct. The patient may therefore participate several times in the study: in different groups, or in the same group, for different allergens. All the above data are collected separately for each new oral immunotherapy (except for socio-demographic data and information on previous oral immunotherapies, which are collected only at the time of inclusion).

In very rare cases, a patient may undergo several oral immunotherapies for the same allergen, but only the first oral immunotherapy (from the time the observatory was set up) will be taken into account in this study. If oral immunotherapy for the same allergen has already been carried out before the observatory was set up, the second oral immunotherapy for this allergen will not be included in the study, as its results will be biased.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patient under 15 years and 9 months,
  • positive diagnosis of food allergy (positive food challenge test or "highly probable allergy", defined by a convincing history, a positive prick test and IgE > 0.35 kUA/L),
  • eligible for oral food challenge
  • accepting the following allergens : hazelnut, walnut, pistachio, cashew, peanut, cow's milk, wheat, egg, sesame, celery, fenugreek, pea, lentils or others

Exclusion criteria

  • Opposition
  • Already received oral challenge for the same allergen.

Treatment and study plan

Oral immunotherapy

Other

Clinical Follow up

Primary outcomes

  1. Age

    Time frame: at inclusion

    For each patient, and for each visit during the treatment period the collection of anthropometric, sociodemographic and medical data relating to oral food challenge will be done

  2. Sex

    Time frame: at inclusion

    For each patient, and for each visit during the treatment period the collection of anthropometric, sociodemographic and medical data relating to oral food challenge will be done

  3. Oral immunotherapies followed before inclusion

    Time frame: at inclusion

    For each patient, and for each visit during the treatment period the collection of anthropometric, sociodemographic and medical data relating to oral food challenge will be done

  4. Determination of comorbidities

    Time frame: at inclusion

    For each patient, and for each visit during the treatment period the collection of anthropometric, sociodemographic and medical data relating to oral food challenge will be done

  5. Determination of allergen under consideration

    Time frame: at inclusion

    For each patient, and for each visit during the treatment period the collection of anthropometric, sociodemographic and medical data relating to oral food challenge will be done

  6. Specific IgE

    Time frame: at inclusion

    For each patient, and for each visit during the treatment period the collection of anthropometric, sociodemographic and medical data relating to oral food challenge will be done

  7. Recombinants

    Time frame: 5 years

    For each patient, and for each visit during the treatment period the collection of anthropometric, sociodemographic and medical data relating to oral food challenge will be done

  8. Cumulative ingested dose

    Time frame: 5 years

    This dose will be determined by mg/food and m/ food protein

  9. Allergic reaction according to the Astier and Coll classification

    Time frame: 5 years

    Astier score for anaphylaxis according to symptoms:

    0- Absent

    1- Abdominal pain spontaneous resolution, Urticaria < 10 papules, Eczema, Rhinoconjunctivitis 2-1 Organ affected, Abdominal pain requiring treatment, Angioedema with laryngeal involvement, Moderate asthma: cough and PEF > 20%.

    3- 2 Affected organs 4- 3 organs affected or Asthma attack requiring treatment or Laryngeal edema or Arterial hypotension 5- Cardiorespiratory impairment requiring ICU admission

  10. Type of oral challenge

    Time frame: 5 years

    Type of ingested food during the oral immunotherapy: fresh food / industrial products

  11. Reception of emergency kit

    Time frame: 5 years

    If the reception of an emergency kit was needed will be determined by yes/no

  12. Second oral food challenge

    Time frame: 5 years

    If a second oral challenge was needed will be determined by yes/no

  13. Tolerance according to reactogenic thresholds for allergens

    Time frame: 5 years

    Subsequent visits will follow the patient's usual routine until the desensitisation threshold is reached or the patient decides to stop the oral immunotherapy protocol.

  14. Amount of reactions IgE mediated

    Time frame: 5 years

    Subsequent visits will follow the patient's usual routine until the desensitisation threshold is reached or the patient decides to stop the oral immunotherapy protocol.

  15. Amount of reactions non IgE mediated

    Time frame: 5 years

    Subsequent visits will follow the patient's usual routine until the desensitisation threshold is reached or the patient decides to stop the oral immunotherapy protocol.

Study contacts

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

Domitille Tristram

CONTACT

[email protected]

+ 33 3 20 22 57 37

Sponsors and collaborators

Lead sponsor

Lille Catholic University

Other

Registry information

Official study title

Paediatric Observatory of Oral Food Tolerance Induction in the Allergy Department of the Saint-Vincent de Paul Hospital in Lille

Acronym: PAUL

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Oct 10, 2024
Registry last updated
Oct 10, 2024

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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