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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paediatric Observatory of Oral Food Tolerance Induction in the Allergy Department of the Saint-Vincent de Paul Hospital in Lille
- ClinicalTrials.gov ID
- NCT06634992
- Acronym / sponsor ID
- PAUL / RNIPH-2021-36
- Conditions
- Child Allergy, IgE-Mediated Allergic Process, Food Allergy
- Keywords
- Food allergy, Food challenge test, IgE-Mediated, Observatory
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Lille Catholic UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 10 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: Oral immunotherapyAllergy to hazelnut, walnut, pistachio, cashew or peanut |
| Group 2 | – | Other: Oral immunotherapyAllergy to cow's milk, wheat or egg |
| Group 3 | – | Other: Oral immunotherapyAllergy to unusual foods: sesame, celery, fenugreek, peas, lentils or others |
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Opposition
- Already received oral challenge for the same allergen.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral immunotherapyClinical Follow up | Other | Group 1, Group 2, Group 3 |
Primary outcome
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
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
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
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
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
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
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
Cumulative ingested dose
Time frame: 5 years
This dose will be determined by mg/food and m/ food protein
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
Type of oral challenge
Time frame: 5 years
Type of ingested food during the oral immunotherapy: fresh food / industrial products
Reception of emergency kit
Time frame: 5 years
If the reception of an emergency kit was needed will be determined by yes/no
Second oral food challenge
Time frame: 5 years
If a second oral challenge was needed will be determined by yes/no
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tomas MORALY principal investigator
Groupement des Hôpitaux de l'Institut Catholique de Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Child Allergy and IgE-Mediated Allergic Process, run by Lille Catholic University at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Domitille Tristram (+ 33 3 20 22 57 37, tristram.domitille@ghicl.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Age (time frame: at inclusion). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2024.