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

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.

Study Overview

• Status: Completed
• Conditions: Immune Tolerance

• Study Type: Observational
• Enrollment (Actual): 70

Contacts and Locations

Study Locations

• France
  • Nord
    • Lomme, Nord, France, 59462
      • Groupement des Hôpitaux de l'institut Catholique de Lille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 17 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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
• Neither Healthcare coverage nor 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
• Neither Healthcare coverage nor 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
• Neither Healthcare coverage nor insurance

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Child, peanut/ nut allergy, no treatment
Child, peanut/nut allergy, tolerance
Non allergic child, without atopia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Allergen-specific biomarkers in blood and saliva	within the 15 days of subject enrollment

Collaborators and Investigators

• Sponsor: Lille Catholic University
• Investigators: Principal Investigator: Catalina ILIESCU, MD, PhD, Direction de la Recherche Médicale, Groupement des Hôpitaux de l'Institut Catholique de Lille

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: November 22, 2013
• First Submitted That Met QC Criteria: November 22, 2013
• First Posted (Estimate): November 27, 2013

Study Record Updates

• Last Update Posted (Estimate): August 19, 2014
• Last Update Submitted That Met QC Criteria: August 18, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Nut and Peanut Hypersensitivity; Peanut Hypersensitivity
• Other Study ID Numbers: RC-P0013