Food Hypersensitivity Clinical Trial
Official title:
Take Away Food Allergy; Inducing Tolerance in Children Allergic to Peanut
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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