Status:
ACTIVE_NOT_RECRUITING
Oral Immunotherapy for Young Children With Peanut Allergy - Small Children OIT
Lead Sponsor:
Karolinska Institutet
Collaborating Sponsors:
Stockholm South General Hospital
Conditions:
Peanut Allergy
Eligibility:
All Genders
1-3 years
Phase:
NA
Brief 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 do...
Detailed 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...
Eligibility Criteria
Inclusion
- Children 1 - 3 years old at inclusion
- Positive baseline challenge at a maximum of the 250 mg peanut protein-dose with at least one objective symptom, or positive peanut challenge performed in the clinic in a similar way within 1 year from study start.
- IgE-ab to peanut and/or Ara h 2 ≥0.1 kUA/l, analyzed within 12 months from start of study
- Written consent for participation in the study from both Guardians
Exclusion
- Other serious illness
- Previously life-threatening anaphylaxis (intensive care), regardless of the triggering agent
- A history of eosinophilic esophagitis (EoE), other eosinophilic gastrointestinal disease, severe chronic gastroesophageal reflux disease (GERD), symptoms of dysphagia, unclear recurrent GI disorders
- Participation in another intervention study, if included in intervention Group
- Severe uncontrolled asthma
- Ongoing medication with biological drugs or oral steroids
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT04511494
Start Date
September 1 2020
End Date
December 1 2025
Last Update
June 4 2025
Active Locations (1)
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1
Forskningsenheten Södersjukhuset
Stockholm, Sweden