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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2019-03-31

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.

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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.

Conditions

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Food Hypersensitivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Peanut oral immunotherapy

Oral immunotherapy with peanut

Group Type ACTIVE_COMPARATOR

Peanut

Intervention Type OTHER

Treatment with peanut in increasing doses until a maintenance dose

Controls

Avoid peanut exposure

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Peanut

Treatment with peanut in increasing doses until a maintenance dose

Intervention Type OTHER

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

Minimum Eligible Age

5 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No