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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

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 Summary:

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.


Sponsor: Oslo University Hospital

Current Primary Outcome: Number of participants with successfull tolerance induction to peanut [ Time Frame: Data will be recorded for 5 years ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Clinical prognostic markers for successful tolerance induction to peanut [ Time Frame: 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 [ Time Frame: 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.


Original Secondary Outcome: Same as current

Information By: Oslo University Hospital

Dates:
Date Received: May 30, 2014
Date Started: March 2014
Date Completion: March 2019
Last Updated: May 3, 2016
Last Verified: May 2016