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

Not Applicable

• Conditions: Food Hypersensitivity
• Interventions: Other: Peanut

• Registration Number: NCT02457416
• Lead Sponsor: Oslo University Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-05-30
• Study First Submitted QC: 2015-05-26
• Study First Posted: 2015-05-29
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-03
• Last Update Posted: 2016-05-04
• Primary Completion: 2019-03
• Study Completion: 2019-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 77

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Peanut oral immunotherapy	Peanut	Oral immunotherapy with peanut

Primary Outcome Measures

Name	Time	Method
Number of participants with successfull tolerance induction to peanut	Data will be recorded for 5 years

Secondary Outcome Measures

Name	Time	Method
Clinical prognostic markers for successful tolerance induction to peanut	Data will be recorded for 5 years	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
Immunological prognostic markers for successful tolerance induction to peanut	Data will be recorded for 5 years	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.

Trial Locations

Locations (1)

Oslo University Hospital, Department of Paediatrics; 🇳🇴 Oslo, Norway