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Take Away Food Allergy; Inducing Tolerance in Children Allergic to Peanut

Primary Purpose

Food Hypersensitivity

Status
Unknown status
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Peanut
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Food Hypersensitivity focused on measuring Peanut allergy, Oral immunotherapy

Eligibility Criteria

5 Years - 15 Years (Child)All SexesDoes not accept healthy 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

Sites / Locations

  • Oslo University Hospital, Department of Paediatrics

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Peanut oral immunotherapy

Controls

Arm Description

Oral immunotherapy with peanut

Avoid peanut exposure

Outcomes

Primary Outcome Measures

Number of participants with successfull tolerance induction to peanut

Secondary Outcome Measures

Clinical prognostic markers for successful tolerance induction to peanut
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
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.

Full Information

First Posted
May 30, 2014
Last Updated
May 3, 2016
Sponsor
Oslo University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02457416
Brief Title
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

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
March 2014 (undefined)
Primary Completion Date
March 2019 (Anticipated)
Study Completion Date
March 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Food Hypersensitivity
Keywords
Peanut allergy, Oral immunotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
77 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Peanut oral immunotherapy
Arm Type
Active Comparator
Arm Description
Oral immunotherapy with peanut
Arm Title
Controls
Arm Type
No Intervention
Arm Description
Avoid peanut exposure
Intervention Type
Other
Intervention Name(s)
Peanut
Intervention Description
Treatment with peanut in increasing doses until a maintenance dose
Primary Outcome Measure Information:
Title
Number of participants with successfull tolerance induction to peanut
Time Frame
Data will be recorded for 5 years
Secondary Outcome Measure Information:
Title
Clinical prognostic markers for successful tolerance induction to peanut
Description
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
Time Frame
Data will be recorded for 5 years
Title
Immunological prognostic markers for successful tolerance induction to peanut
Description
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.
Time Frame
Data will be recorded for 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Geir Håland, MD PhD
Organizational Affiliation
Oslo University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Oslo University Hospital, Department of Paediatrics
City
Oslo
ZIP/Postal Code
0424
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
31013372
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.
Results Reference
derived
PubMed Identifier
30225844
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.
Results Reference
derived

Learn more about this trial

Take Away Food Allergy; Inducing Tolerance in Children Allergic to Peanut

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