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
|Condition or disease||Intervention/treatment||Phase|
|Food Hypersensitivity||Other: Peanut||Not Applicable|
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|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Active Comparator: Peanut oral immunotherapy
Oral immunotherapy with peanut
Treatment with peanut in increasing doses until a maintenance dose
No Intervention: Controls
Avoid peanut exposure
- Number of participants with successfull tolerance induction to peanut [ Time Frame: Data will be recorded for 5 years ]
- 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
- 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.
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
|Oslo University Hospital, Department of Paediatrics|
|Oslo, Norway, 0424|
|Study Chair:||Geir Håland, MD PhD||Oslo University Hospital|