Clinical trial NCT02457416: Take Away Food Allergy; Inducing Tolerance in Children Allergic to Peanut
Official title: Take Away Food Allergy; Inducing Tolerance in Children Allergic to Peanut
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Food Hypersensitivity
Keywords: Peanut allergy
Oral immunotherapy
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2015-05-29
Enrollment: 77
Sex: ALL
Minimum age (years): 5
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with successfull tolerance induction to peanut
timeFrame: Data will be recorded for 5 years
Secondary outcomes:
measure: Clinical prognostic markers for successful tolerance induction to peanut
timeFrame: Data will be recorded for 5 years
measure: Immunological prognostic markers for successful tolerance induction to peanut
timeFrame: Data will be recorded for 5 years
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital, Department of Paediatrics
Study officials:
affiliation: Oslo University Hospital
name: Geir Håland, MD PhD
role: STUDY_CHAIR
References:
citation: Reier-Nilsen T, Carlsen KCL, Michelsen MM, Drottning S, Carlsen KH, Zhang C, Borres MP, Haland G. Parent and child perception of quality of life in a randomized controlled peanut oral immunotherapy trial. Pediatr Allergy Immunol. 2019 Sep;30(6):638-645. doi: 10.1111/pai.13066. Epub 2019 Jul 25.
citation: Reier-Nilsen T, Michelsen MM, Lodrup Carlsen KC, Carlsen KH, Mowinckel P, Nygaard UC, Namork E, Borres MP, Haland G. Feasibility of desensitizing children highly allergic to peanut by high-dose oral immunotherapy. Allergy. 2019 Feb;74(2):337-348. doi: 10.1111/all.13604. Epub 2018 Oct 8.