Take Away Food Allergy; Inducing Tolerance in Children Allergic to Peanut

Study Overview
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Brief Summary
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The purpose of the study is to identify prognostic markers and possible success rate of tolerance induction to peanut allergens in children allergic to peanut.

Detailed Description
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The study is an open randomized controlled study on oral immunotherapy including 60 children (40 on active treatment, 20 controls) with primary peanut allergy. The study has 4 phases: 1: inclusion/randomization including a double blind placebo controlled food Challenge 2: bi weekly up-dosing to maintenance dose after 48 weeks, 3: maintenance period of 3 years 4: 1 year follow up after end of treatment. Clinical parameters as well as immunological (serological and cellular) will be recorded at inclusion, after 3 months of up-dosing, at end of up-dosing, after 1 and 3 years of maintenance treatment and after 3 and 12 year of follow up.

Official Title
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Take Away Food Allergy; Inducing Tolerance in Children Allergic to Peanut

Conditions
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Food Hypersensitivity

Intervention / Treatment
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* Other: Peanut


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Positive skin prick test or IgE to peanut Age 5-15 yrs Primary peanut allergy verified by objective symptoms to DBPCFC by a dose of 3 mg or more peanut potein Exclusion Criteria: Non controlled asthma (by asthma control test, ACT) Allergy/intolerance to any other ingredients in the vehicle used for the peanut DBPCFC Current or previous allergen specific immunotherapy Cardiac disease with increased risk of serious anaphylaxis Severe atopic skin disease Diabetes mellitus Severe disease that interferes with adherence to study protocol

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 15 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Peanut oral immunotherapy<br>Oral immunotherapy with peanut | Other: Peanut<br>* Treatment with peanut in increasing doses until a maintenance dose<br>|
| No Intervention: Controls<br>Avoid peanut exposure | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with successfull tolerance induction to peanut |  | Data will be recorded for 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical prognostic markers for successful tolerance induction to peanut | Clinical markers like severity of peanut allergy during double blind placebo controlled food challenge (DBPCFC), threshold level on DBPCFC, side effects during up dosing, maximum peanut dose reached, concomitant other atopic diseases will be assessed | Data will be recorded for 5 years | 
| Immunological prognostic markers for successful tolerance induction to peanut | Immunologic markers: Immunoglobulin E (IgE) to peanut and its components, total IgE, Immunoglobulin G4 to peanut and its components, Basophil activation test will be assessed. | Data will be recorded for 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peanut allergy, Oral immunotherapy