Clinical trial NCT06634992: Observatory of the Lille Paediatric Allergy Unit
Official title: Paediatric Observatory of Oral Food Tolerance Induction in the Allergy Department of the Saint-Vincent de Paul Hospital in Lille
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Child Allergy
IgE-Mediated Allergic Process
Food Allergy
Keywords: Food allergy
Food challenge test
IgE-Mediated
Observatory
Lead sponsor: Lille Catholic University
Sponsor class: OTHER
First posted: 2024-10-10
Enrollment: 1000
Sex: ALL
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All eligible patients consulting at the allergology service of the Saint Vincent Hospital, Lille, France will be informed and included, unless they object.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Age
timeFrame: at inclusion
measure: Sex
timeFrame: at inclusion
measure: Oral immunotherapies followed before inclusion
timeFrame: at inclusion
measure: Determination of comorbidities
timeFrame: at inclusion
measure: Determination of allergen under consideration
timeFrame: at inclusion
measure: Specific IgE
timeFrame: at inclusion
measure: Recombinants
timeFrame: 5 years
measure: Cumulative ingested dose
timeFrame: 5 years
measure: Allergic reaction according to the Astier and Coll classification
timeFrame: 5 years
measure: Type of oral challenge
timeFrame: 5 years
measure: Reception of emergency kit
timeFrame: 5 years
measure: Second oral food challenge
timeFrame: 5 years
measure: Tolerance according to reactogenic thresholds for allergens
timeFrame: 5 years
measure: Amount of reactions IgE mediated
timeFrame: 5 years
measure: Amount of reactions non IgE mediated
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Lille
country: France
facility: Groupement de l'Institut Catholique de Lille - Hôpital Saint Vincent de Paul
Study officials:
affiliation: Groupement des Hopitaux de l'institut catholique de Lille
name: Tomas MORALY
role: PRINCIPAL_INVESTIGATOR
References: