Oral Immunotherapy for Young Children With Peanut Allergy - Small Children OIT
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- STATUS
- Recruiting
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- End date
- Dec 10, 2024
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- participants needed
- 100
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- sponsor
- Karolinska Institutet
Summary
Open label study with peanut oral immunotherapy (OIT). Peanut allergic children aged >1 and <4 years of age will be randomized 2:1 to:
- Peanut OIT with slow up-dosing (40-60 weeks) up to a maintenance dose of 286 mg daily oral peanut protein and
- Control group with peanut allergic children who do not undergo OIT.
- In addition, a group of healthy children without allergic diseases will be included in the study.
The primary outcome, sustained unresponsiveness (i.e. tolerance) to 600 mg peanut protein after 3 years of OIT, efficacy and safety will be compared between group 1 and 2. Group 3 is a control group for analyses of immunological markers.
Description
Problem: Today there is no clinically available treatment for peanut allergy. Oral Immunotherapy (OIT) studies have shown promising results, particularly in younger children (<4 years).
Intervention: Peanut OIT in children aged >1 and <4 years with peanut allergy (clinical symptoms at peanut challenge and IgE >0.1 kU /l to peanut and/or Ara h 2).
Comparison: Three groups are compared. Peanut allergic children are randomized 2:1 to group 1 (active OIT) or group 2 (control). Group 3 consists of age-matched healthy controls:
Group 1; Children with peanut allergy receiving peanut OIT, slow up-dosing, 40-60 weeks, until the maintenance dose 286 mg peanut protein. Three years' treatment.
Group 2; Age-matched children with peanut allergy who do not undergo OIT peanut. Peanut challenge one and three years after inclusion.
Group 3; Healthy, non-allergic, age-matched children. No challenges are performed in this group.
Inclusion of study subjects: A review of samples sent to the Karolinska University Laboratory for IgE-ab responses to peanut/Ara h 2 for children in the Stockholm area aged 1-<4 years is used for identification of potential participants to whom a letter is sent with information about the study. The families are randomized 2:1 to OIT or control group, group 1 or group 2. Children without allergies, healthy Controls (group 3), will be identified through the day surgery at Astrid Lindgren's Children's Hospital.
Outcomes: The primary outcome is defined as sustained unresponsiveness to 775 mg peanut protein (cumulative dose) at an open oral peanut challenge 4 weeks after 3 years of OIT was stopped (group 1 and 2).
Secondary outcomes are adverse events among peanut allergic children with/without OIT treatment (group 1 and 2), and changes in quality of life parameters and immunological markers (group, 1, 2, 3).
Details
| Condition | peanut allergy, allergy to peanuts |
|---|---|
| Treatment | Peanut (bamba) |
| Clinical Study Identifier | NCT04511494 |
| Sponsor | Karolinska Institutet |
| Last Modified on | 10 September 2021 |
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