Take Away Food Allergy; Inducing Tolerance in Children Allergic to Peanut
1 other identifier
interventional
77
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2014
CompletedFirst Submitted
Initial submission to the registry
May 30, 2014
CompletedFirst Posted
Study publicly available on registry
May 29, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2019
CompletedMay 4, 2016
May 1, 2016
5 years
May 30, 2014
May 3, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of participants with successfull tolerance induction to peanut
Data will be recorded for 5 years
Secondary Outcomes (2)
Clinical prognostic markers for successful tolerance induction to peanut
Data will be recorded for 5 years
Immunological prognostic markers for successful tolerance induction to peanut
Data will be recorded for 5 years
Study Arms (2)
Peanut oral immunotherapy
ACTIVE COMPARATOROral immunotherapy with peanut
Controls
NO INTERVENTIONAvoid peanut exposure
Interventions
Treatment with peanut in increasing doses until a maintenance dose
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Oslo University Hospital, Department of Paediatrics
Oslo, 0424, Norway
Related Publications (2)
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.
PMID: 31013372DERIVEDReier-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.
PMID: 30225844DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Geir Håland, MD PhD
Oslo University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant PhD/Post doc
Study Record Dates
First Submitted
May 30, 2014
First Posted
May 29, 2015
Study Start
March 1, 2014
Primary Completion
March 1, 2019
Study Completion
March 1, 2019
Last Updated
May 4, 2016
Record last verified: 2016-05