Overview

This trial is active, not recruiting.

Condition food hypersensitivity
Treatment peanut
Sponsor Oslo University Hospital
Start date March 2014
End date March 2019
Trial size 77 participants
Trial identifier NCT02457416, 2013/430

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Oral immunotherapy with peanut
peanut
Treatment with peanut in increasing doses until a maintenance dose
(No Intervention)
Avoid peanut exposure

Primary Outcomes

Measure
Number of participants with successfull tolerance induction to peanut
time frame: Data will be recorded for 5 years

Secondary Outcomes

Measure
Clinical prognostic markers for successful tolerance induction to peanut
time frame: Data will be recorded for 5 years
Immunological prognostic markers for successful tolerance induction to peanut
time frame: Data will be recorded for 5 years

Eligibility Criteria

Male or female participants from 5 years up to 15 years old.

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

Additional Information

Official title Take Away Food Allergy; Inducing Tolerance in Children Allergic to Peanut
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Oslo University Hospital.