Take Away Food Allergy; Inducing Tolerance in Children Allergic to Peanut
Status
Conditions
Treatments
Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
77 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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