Status:
RECRUITING
Randomized Controlled Trial of Slow Multiallergen Oral Immunotherapy in Young Children
Lead Sponsor:
Karolinska Institutet
Conditions:
Food Allergy
Oral Immunotherapy for Food Allergy
Eligibility:
All Genders
6-3 years
Phase:
NA
Brief Summary
The aim is to study whether a multiallergen oral immunotherapy (OIT) strategy with slow up-dosing and low treatment dose against food allergy in young children (0.5-3 years) is safe and effective, a m...
Detailed Description
Today, there is no established curative treatment for food allergies, and those affected must avoid the food that triggers symptoms. The most studied method is oral immunotherapy (OIT) which have main...
Eligibility Criteria
Inclusion
- 5-3 years old at inclusion with IgE (\>0.1 kUA/l) against at least one allergen (wheat, lentils, egg, milk, soy, walnut, hazelnut, peanut, almond, cashew).
- Written consent for participation in the study for both guardians.
- 80 children (group A and B) also need a positive baseline food challenge.
- Children with a negative food challenge (group C and D) (number not determined) do not react at the baseline challenge.
Exclusion
- other serious illness
- previous life-threatening anaphylaxis (intensive care)
- eosinophilic esophagitis
- eosinophilic gastrointestinal disease
- severe chronic gastroesophageal reflux disease
- unclear recurrent GI complaints
- low body weight \<2SD
- participation in another intervention study if included in intervention group
- severe uncontrolled asthma
- medication with biological drugs or oral steroids.
Key Trial Info
Start Date :
November 8 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06533462
Start Date
November 8 2024
End Date
December 1 2027
Last Update
September 16 2025
Active Locations (1)
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1
Södersjukhuset
Stockholm, Sweden, 11883