Ignite Creation Date:
2024-10-25 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06634992
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-08
Brief Title:
Observatory of the Lille Paediatric Allergy Unit
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Paediatric Observatory of Oral Food Tolerance Induction in the Allergy Department of the Saint-Vincent de Paul Hospital in Lille
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PAUL
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
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 peanut2 allergen to cows 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 patients 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 dateDuring 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 investigators 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
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 peanut2 allergen to cows 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 patients 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 dateDuring 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 investigators 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None