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

Food Hypersensitivity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02457416
• Other study ID #: 2013/430
• Status: Active, not recruiting
• Phase: N/A
• First received: May 30, 2014
• Last updated: May 3, 2016
• Start date: March 2014
• Est. completion date: March 2019

Study information

• Verified date: May 2016
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Regional Ethics Commitee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 77
• Est. completion date: March 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 15 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Food Hypersensitivity
• Hypersensitivity

Intervention

Other:
• Peanut
Treatment with peanut in increasing doses until a maintenance dose

Locations

Country	Name	City	State
Norway	Oslo University Hospital, Department of Paediatrics	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with successfull tolerance induction to peanut		Data will be recorded for 5 years	No
Secondary	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	No
Secondary	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	No