Immunologic Profile of Children With Severe Allergies to Peanuts and Nuts After Induction of Tolerance (TOY)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Lille Catholic University
Sponsor:
Information provided by (Responsible Party):
Lille Catholic University
ClinicalTrials.gov Identifier:
NCT01996774
First received: November 22, 2013
Last updated: NA
Last verified: November 2013
History: No changes posted
  Purpose

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.


Condition
Immune Tolerance

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Immunologic Profile of Children and Teenagers With Severe Allergy to Peanuts and Nuts After Induction of Tolerance: a Pilot Project

Resource links provided by NLM:


Further study details as provided by Lille Catholic University:

Primary Outcome Measures:
  • Allergen-specific biomarkers in blood and saliva [ Time Frame: within the 15 days of subject enrollment ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Blood, serum, saliva


Estimated Enrollment: 90
Study Start Date: February 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Child, peanut/ nut allergy, no treatment
Child, peanut/nut allergy, tolerance
Non allergic child, without atopia

  Eligibility

Ages Eligible for Study:   1 Year to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Children with allergy to peanuts and nuts hospitalized for initial diagnosis or for treatment in the Allergology Center of GHICL.

Criteria

Group 1:

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • No coverage by the Social Insurance

Group 2:

Inclusion criteria

  • 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.

Exclusion Criteria:

  • 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
  • No coverage by the Social Insurance

Group 3:

Inclusion criteria:

  • Children (between 1 and 16 years old)
  • 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

Exclusion Criteria:

  • 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
  • No coverage by the Social Insurance
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01996774

Contacts
Contact: Magali DEMILLY, PhD, CTC +33 3 20 22 57 00 demilly.magalie@ghicl.net
Contact: Gabriela CERTAD, MD, PhD +33 3 20 22 57 34 Certad.Gabriela@ghicl.net

Locations
France
Groupement des Hôpitaux de l'Institut Catholique de Lille Recruiting
Lomme, Nord, France, 59462
Contact: Catalina Iliescu, MD, PhD    03.20.22.52.69    iliescu.catalina@ghicl.net   
Principal Investigator: Catalina Iliescu, MD, PhD         
Sub-Investigator: Agnès Charpentier, MD, PhD         
Sub-Investigator: Anne Decoster, MD         
Sub-Investigator: Marie Christine Castelain, MD         
Sub-Investigator: Nicolas Kalach, MD, PhD         
Sponsors and Collaborators
Lille Catholic University
Investigators
Principal Investigator: Catalina ILIESCU, MD, PhD Direction de la Recherche Médicale, Groupement des Hôpitaux de l'Institut Catholique de Lille
  More Information

No publications provided

Responsible Party: Lille Catholic University
ClinicalTrials.gov Identifier: NCT01996774     History of Changes
Other Study ID Numbers: RC-P0013
Study First Received: November 22, 2013
Last Updated: November 22, 2013
Health Authority: France: Ministry of Health

Additional relevant MeSH terms:
Peanut Hypersensitivity
Food Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on July 20, 2014