Food Hypersensitivity
Conditions
Keywords
Peanut allergy, Oral immunotherapy
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.
Interventions
OTHERPeanut
Treatment with peanut in increasing doses until a maintenance dose
Sponsors
Oslo University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 15 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with successfull tolerance induction to peanut | Data will be recorded for 5 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Norway
Outcome results
None listed