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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peanut oral immunotherapy | Active Comparator | Oral immunotherapy with peanut |
|
| Controls | No Intervention | Avoid peanut exposure |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peanut | Other | Treatment with peanut in increasing doses until a maintenance dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with successfull tolerance induction to peanut | Data will be recorded for 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Data will be recorded for 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Geir HÃ¥land, MD PhD | Oslo University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oslo University Hospital, Department of Paediatrics | Oslo | 0424 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31013372 | Derived | 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. | |
| 30225844 | Derived |
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| ID | Term |
|---|---|
| D005512 | Food Hypersensitivity |
| D021183 | Peanut Hypersensitivity |
| ID | Term |
|---|---|
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D000074924 | Nut and Peanut Hypersensitivity |
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| 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. | Data will be recorded for 5 years |
| 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. |