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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Immune Tolerance

Age range

1 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Groupement des Hôpitaux de l'Institut Catholique de Lille

Lomme, Nord, 59462, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Allergen-specific biomarkers in blood and saliva

Time frame: within the 15 days of subject enrollment

Sponsors and collaborators

Lead sponsor

Lille Catholic University

Other

Registry information

Official study title

Immunologic Profile of Children and Teenagers With Severe Allergy to Peanuts and Nuts After Induction of Tolerance: a Pilot Project

Acronym: TOY

Important dates

Study start: 2012
Primary completion: 2014
Study completion: 2014
First posted: Nov 27, 2013
Registry last updated: Aug 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed