Immune ToleranceTOYNCT01996774
Immunologic Profile of Children With Severe Allergies to Peanuts and Nuts After Induction of Tolerance
An observational study of Immune Tolerance, run by Lille Catholic University at 1 site in France.
Trial summary
Many authors propose the strict avoidance of allergenic food as the only treatment for children known to be allergic to certain food. However, it has been observed an increase of the frequency and severity of the allergic accidents in these children in the long term. Read more about this study
- Who is it for?
- Ages 1 year to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Immune Tolerance
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2012to Mar 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
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 1 year to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children with allergy to peanuts and nuts hospitalized for initial diagnosis or for treatment in the Allergology Center of GHICL.
Who may be able to join
- Children (between 1 and 16 years old)known to have an allergy to peanuts and nuts detected by specific IgE, specific recombinant rArah (1 to 8) and R Cora and other allergens with a value superior or equal to 5KU/L.
- Child, parents or legal representatives have given informed consent to participate in the study after being informed in details about the protocol.
- Children (between 1 and 16 years old)known to have an allergy to peanuts and nuts detected by specific IgE, specific recombinant rArah (1 to 8) and R Cora and other allergens with a value superior or equal to 5KU/L
- Doubling the values of the threshold after second oral challenge compared to the tests of reference
- Child, parents or legal representatives have given informed consent to participate in the study after being informed in details about the protocol.
- Children (between 1 and 16 years old)
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- No allergy to peanuts or nuts
- No antecedents of atopia
- Child, parents or legal representatives have given informed consent to participate in the study after being informed in details about the protocol
Who cannot join
- Immunodeficiency,
- Children or parents in disagreement with the study
- Children without standard diagnostic test at recruitment (oral provocation test vs. placebo)
- Children who reacted to placebo
- Children with uncontrolled asthma or respiratory disease
- Treatment with oral antihistaminic or corticoids one week before
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- Neither Healthcare coverage nor insurance
- Group 2:
- Immunodeficiency,
- Children or parents in disagreement with the study
- Children without standard diagnostic test at recruitment (oral provocation test vs placebo)
- Children who reacted to placebo
- Children with uncontrolled asthma or respiratory disease
- Treatment with oral antihistaminic or corticoids one week before
- Neither Healthcare coverage nor insurance
- Group 3:
- Immunodeficiency,
- Children or parents in disagreement with the study
- Children without standard diagnostic test at recruitment (oral provocation test vs. placebo)
- Children who reacted to placebo
- Children with uncontrolled asthma or respiratory disease
- Treatment with oral antihistaminic or corticoids one week before
- Neither Healthcare coverage nor insurance
Trial locations and contacts
1 site in 1 country.
France1 site
Groupement des Hôpitaux de l'Institut Catholique de Lille
Lomme, Nord, 59462
About this study
Official title: Immunologic Profile of Children and Teenagers With Severe Allergy to Peanuts and Nuts After Induction of Tolerance: a Pilot Project
Many authors propose the strict avoidance of allergenic food as the only treatment for children known to be allergic to certain food. However, it has been observed an increase of the frequency and severity of the allergic accidents in these children in the long term. Other teams have suggested treating these allergies (in particular peanut allergies) by controlled and progressive reintroduction of the allergenic food. A good tolerance and a prevention of allergic reactions consecutive to the ingestion of the same allergenic food were observed. The immunological mechanisms of this type of treatment are not well known.
A decrease of specific IgE and an increase of IgG4 have been observed in the case of egg allergies after this kind of treatment. Certain experiments realized in mice models testing the allergenic stimulation challenge showed an increase of lymphocytes T regulators (foxp3+ , CD4+, CD25+), stimulated by dendritic cells, and also an increase of interleukin 10, leading to the modification of the balance between Th1 and Th2.Our hypothesis is that after treating allergies by the reintroduction of the allergenic food, the immunological mechanism of acquisition of tolerance is associated to variations in populations of lymphocytes and in the activation or decrease of pro and anti-inflammatory cytokines. This reaction will be studied in two groups: 1. Children with a confirmed allergy to peanuts or nuts and 2. Children without antecedents of allergy or familiar atopy.
- Conditions
- Immune Tolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Child, peanut/ nut allergy, no treatment | Not described | |
| Child, peanut/nut allergy, tolerance | Not described | |
| Non allergic child, without atopia | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Allergen-specific biomarkers in blood and saliva
Measured: within the 15 days of subject enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2013 (estimated)
- Study startFeb 2012
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune ToleranceStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lille Catholic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catalina ILIESCU, MD, PhD, Principal investigator, Direction de la Recherche Médicale, Groupement des Hôpitaux de l'Institut Catholique de Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01996774
- Sponsor's protocol ID
- RC-P0013
- Acronym
- TOY
- Status last verified
- Aug 2014
- First submitted
- 22 Nov 2013
- Last updated
- 19 Aug 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunologic Profile of Children and Teenagers With Severe Allergy to Peanuts and Nuts After Induction of Tolerance: a Pilot Project
- ClinicalTrials.gov ID
- NCT01996774
- Acronym / sponsor ID
- TOY / RC-P0013
- Conditions
- Immune Tolerance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Lille Catholic UniversityUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 27 Nov 2013 (estimated)
- 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.
Many authors propose the strict avoidance of allergenic food as the only treatment for children known to be allergic to certain food. However, it has been observed an increase of the frequency and severity of the allergic accidents in these children in the long term. Other teams have suggested treating these allergies (in particular peanut allergies) by controlled and progressive reintroduction of the allergenic food. A good tolerance and a prevention of allergic reactions consecutive to the ingestion of the same allergenic food were observed. The immunological mechanisms of this type of treatment are not well known.
A decrease of specific IgE and an increase of IgG4 have been observed in the case of egg allergies after this kind of treatment. Certain experiments realized in mice models testing the allergenic stimulation challenge showed an increase of lymphocytes T regulators (foxp3+ , CD4+, CD25+), stimulated by dendritic cells, and also an increase of interleukin 10, leading to the modification of the balance between Th1 and Th2.Our hypothesis is that after treating allergies by the reintroduction of the allergenic food, the immunological mechanism of acquisition of tolerance is associated to variations in populations of lymphocytes and in the activation or decrease of pro and anti-inflammatory cytokines. This reaction will be studied in two groups: 1. Children with a confirmed allergy to peanuts or nuts and 2. Children without antecedents of allergy or familiar atopy.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Child, peanut/ nut allergy, no treatment | – | – |
| Child, peanut/nut allergy, tolerance | – | – |
| Non allergic child, without atopia | – | – |
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children with allergy to peanuts and nuts hospitalized for initial diagnosis or for treatment in the Allergology Center of GHICL.
Key inclusion criteria (9 listed)
- Children (between 1 and 16 years old)known to have an allergy to peanuts and nuts detected by specific IgE, specific recombinant rArah (1 to 8) and R Cora and other allergens with a value superior or equal to 5KU/L.
- Child, parents or legal representatives have given informed consent to participate in the study after being informed in details about the protocol.
- Children (between 1 and 16 years old)known to have an allergy to peanuts and nuts detected by specific IgE, specific recombinant rArah (1 to 8) and R Cora and other allergens with a value superior or equal to 5KU/L
- Doubling the values of the threshold after second oral challenge compared to the tests of reference
- Child, parents or legal representatives have given informed consent to participate in the study after being informed in details about the protocol.
Key exclusion criteria (23 listed)
- Immunodeficiency,
- Children or parents in disagreement with the study
- Children without standard diagnostic test at recruitment (oral provocation test vs. placebo)
- Children who reacted to placebo
- Children with uncontrolled asthma or respiratory disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Allergen-specific biomarkers in blood and saliva
Time frame: within the 15 days of subject enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2014.
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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. This study is not recruiting at the moment.
Catalina ILIESCU, MD, PhD principal investigator
Direction de la Recherche Médicale, 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 Immune Tolerance, 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 9 inclusion and 23 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: finished, as of the sponsor's last update on 19 Aug 2014. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Allergen-specific biomarkers in blood and saliva (time frame: within the 15 days of subject enrollment). 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 19 Aug 2014.