Child AllergyPAULNCT06634992
Observatory of the Lille Paediatric Allergy Unit
An observational study of Child Allergy and IgE-Mediated Allergic Process, run by Lille Catholic University at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 16 years
- Conditions the study is for
- Child Allergy, IgE-Mediated Allergic Process, Food Allergy
- What is being tested?
- Oral immunotherapy
- Type of treatment
- Pill or oral medicine
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2022to 31 Dec 2024
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 16 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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
Who cannot join
- Opposition
- Already received oral challenge for the same allergen.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Groupement de l'Institut Catholique de Lille - Hôpital Saint Vincent de Paul
Lille, 59000
Tomas MORALY
About this study
Official title: Paediatric Observatory of Oral Food Tolerance Induction in the Allergy Department of the Saint-Vincent de Paul Hospital in Lille
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.
Read the 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.
- Conditions
- Child Allergy, IgE-Mediated Allergic Process, Food Allergy
- Being tested
- Oral immunotherapy
- Keywords
- Food allergy, Food challenge test, IgE-Mediated, Observatory
- Medical subject headings
- Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral immunotherapyOther
Clinical Follow up
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Allergy to hazelnut, walnut, pistachio, cashew or peanut Receives: Other: Oral immunotherapy | |
| Group 2 | Allergy to cow's milk, wheat or egg Receives: Other: Oral immunotherapy | |
| Group 3 | Allergy to unusual foods: sesame, celery, fenugreek, peas, lentils or others Receives: Other: Oral immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Age
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
Measured: at inclusion
Sex
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
Measured: at inclusion
Oral immunotherapies followed before 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
Measured: at inclusion
Determination of comorbidities
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
Measured: at inclusion
Determination of allergen under consideration
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
Measured: at inclusion
Specific IgE
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
Measured: at inclusion
Recombinants
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
Measured: 5 years
Cumulative ingested dose
This dose will be determined by mg/food and m/ food protein
Measured: 5 years
Allergic reaction according to the Astier and Coll classification
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
Measured: 5 years
Type of oral challenge
Type of ingested food during the oral immunotherapy: fresh food / industrial products
Measured: 5 years
Reception of emergency kit
If the reception of an emergency kit was needed will be determined by yes/no
Measured: 5 years
Second oral food challenge
If a second oral challenge was needed will be determined by yes/no
Measured: 5 years
Tolerance according to reactogenic thresholds for allergens
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.
Measured: 5 years
Amount of reactions IgE mediated
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.
Measured: 5 years
Amount of reactions non IgE mediated
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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start1 Jan 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child AllergyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lille Catholic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tomas MORALY, Principal investigator, Groupement des Hôpitaux de l'Institut Catholique de Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06634992
- Sponsor's protocol ID
- RNIPH-2021-36
- Acronym
- PAUL
- Status last verified
- Oct 2024
- First submitted
- 8 Oct 2024
- Last updated
- 10 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No