Peanut Oral Induction Tolerance in Peanut's Allergic Teenagers

Study Overview
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Brief Summary
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The primary purpose of the protocol is to evaluate the efficacy of a protocol for induction of tolerance to peanut ingestion increasing doses. The secondary purpose is to determine the interest of a prolonged maintenance therapy

Detailed Description
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Prospective randomized double blind, placebo controlled, protocol in two phases: 1/ active treatment versus placebo for induction phase; 2/ long versus short maintenance

Official Title
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Peanut Oral Induction Tolerance in Peanut's Allergic Teenagers

Conditions
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Peanut Allergy

Intervention / Treatment
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* Drug: arachid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adolescents between 12 and 18 years Clinical History of allergic manifestation within one hour of ingestion of peanuts or Double-Blind, Placebo-Controlled Food Challenges (DBPCFCs) peanut positive below the threshold of 2 grams Bad reaction peanut demonstrated by positive Patch Test (PT ≥ 3 mm above the negative control) and specific IgE f13> 12 IU / mL and / or rAra h2> 5.8 IU / mL Previous follow at least 1 year Exclusion Criteria: Lack of response during the initial DBPCFCs to the cumulative dose of 2 grams of peanut or instant dose of 1 gram of peanut Uncontrolled asthma and / or severe over the previous year Atopic dermatitis uncontrolled Initial severe anaphylaxis requiring hospitalization in intensive care Presence of a major allergy with anaphylaxis at another allergen risk (milk, egg, nuts, or other) Home away from a center could support a severe reaction in emergency Lack of motivation and understanding of parents and / or child Incapacity to establish a daily logbook of clinical monitoring to support severe reaction after eating peanut to follow a regular peanut ingestion protocol

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treatment<br>Prospective randomized double blind, placebo controlled, protocol in two phases: 1/ active treatment versus placebo for induction phase; 2/ long versus short maintenance | Drug: arachid<br> <br> |
| Placebo Comparator: placebo<br>Prospective randomized double blind, placebo controlled, protocol in two phases: 1/ active treatment versus placebo for induction phase; 2/ long versus short maintenance | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients which tolerate the cumulative dose of 2 grams of peanut at the end of the first phase of 24 weeks between treatment and placebo groups |  | at 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients had quadrupled their tolerance to peanut at the end of induction phase |  | at 24 weeks | 
| Percentage of patients with adverse effects during induction phase |  | at 24 weeks | 
| Modifications of the immune profile showing a desensitization to peanut |  | at 24 weeks | 
| Percentage of patients which tolerate the cumulative dose of 2 grams of peanut during a Double-Blind, Placebo-Controlled Food Challenges (DBPCFCs) after 24 weeks without traces eviction diet after the end of maintenance phase |  | at 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Teenager, Peanut, OIT (Oral Induction Tolerance)