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

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ClinicalTrials.gov Identifier: NCT02457416
Recruitment Status : Active, not recruiting
First Posted : May 29, 2015
Last Update Posted : May 4, 2016
Sponsor:
Information provided by (Responsible Party):
Geir Håland, Oslo University Hospital

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.

Condition or disease Intervention/treatment Phase
Food Hypersensitivity Other: Peanut Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 77 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Take Away Food Allergy; Inducing Tolerance in Children Allergic to Peanut
Study Start Date : March 2014
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Peanut oral immunotherapy
Oral immunotherapy with peanut
Other: Peanut
Treatment with peanut in increasing doses until a maintenance dose

No Intervention: Controls
Avoid peanut exposure



Primary Outcome Measures :
  1. Number of participants with successfull tolerance induction to peanut [ Time Frame: Data will be recorded for 5 years ]

Secondary Outcome Measures :
  1. Clinical prognostic markers for successful tolerance induction to peanut [ Time Frame: Data will be recorded for 5 years ]
    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

  2. Immunological prognostic markers for successful tolerance induction to peanut [ Time Frame: Data will be recorded for 5 years ]
    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.



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Ages Eligible for Study:   5 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02457416


Locations
Norway
Oslo University Hospital, Department of Paediatrics
Oslo, Norway, 0424
Sponsors and Collaborators
Oslo University Hospital
Investigators
Study Chair: Geir Håland, MD PhD Oslo University Hospital

Responsible Party: Geir Håland, Consultant PhD/Post doc, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT02457416     History of Changes
Other Study ID Numbers: 2013/430
First Posted: May 29, 2015    Key Record Dates
Last Update Posted: May 4, 2016
Last Verified: May 2016

Keywords provided by Geir Håland, Oslo University Hospital:
Peanut allergy
Oral immunotherapy

Additional relevant MeSH terms:
Hypersensitivity
Food Hypersensitivity
Immune System Diseases
Hypersensitivity, Immediate