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Oral Immunotherapy for Young Children With Peanut Allergy - Small Children OIT
Sponsor: Karolinska Institutet
Summary
Open label study with peanut oral immunotherapy (OIT). Peanut allergic children aged 1-3 years of age will be randomized 2:1 to: 1. Peanut OIT with slow up-dosing (40-60 weeks) up to a maintenance dose of 285 mg daily oral peanut protein or 2. Control group with peanut allergic children who do not undergo OIT. 3. In addition, a group of healthy children without allergic diseases will be included in the study. The primary outcome is tolerance to at least 750 mg peanut protein at a challenge after 3 years and sustained unresponsiveness (i.e. tolerance) to 750 mg peanut protein after 3 years of OIT followed by 4-6 weeks of avoidance. Efficacy and safety will be compared between group 1 and 2. Group 3 is a control group for analyses of immunological markers.
Official title: Oral Immunotherapy for Young Children With Peanut Allergy - Small Children OIT (SmaChO)
Key Details
Gender
All
Age Range
1 Year - 3 Years
Study Type
INTERVENTIONAL
Enrollment
114
Start Date
2020-09-01
Completion Date
2025-12
Last Updated
2025-06-04
Healthy Volunteers
No
Conditions
Interventions
Peanut (bamba)
OIT peanut with slow-updosing for 40-60 weeks followed by maintenance. 3 years treatment.
Locations (1)
Forskningsenheten Södersjukhuset
Stockholm, Sweden