Actively Recruiting
Randomized Controlled Trial of Slow Multiallergen Oral Immunotherapy in Young Children
Led by Karolinska Institutet · Updated on 2025-09-16
80
Participants Needed
1
Research Sites
159 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 method to cure food allergy and to prevent the development of new food allergies. Clinical randomized controlled (1:1) blinded interventional trial (RCT) with 2 intervention arms (group A and B). Among 80 children reacting at the multiallergen food challenge, 40 children will be randomized to receive OIT (oral immunotherapy) with multiallergen powder with a final dose of approximately 200 mg protein of each included food (egg, milk, soy, wheat, walnut, peanut, hazelnut, cashew, almond, lentils)(group A) or to receive placebo powder (gluten-free oatmeal) (group B). A sub-analysis will be performed of the children not reacting to the baseline challenge, who will be randomized to eat a low dose of the multiallergen powder (group C) or placebo powder (gluten-free oatmeal) (group D) and no specific advice.
CONDITIONS
Official Title
Randomized Controlled Trial of Slow Multiallergen Oral Immunotherapy in Young Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 0.5 to 3 years at inclusion with IgE >0.1 kUA/L against at least one of these allergens: wheat, lentils, egg, milk, soy, walnut, hazelnut, peanut, almond, cashew
- Written consent for study participation from both guardians
- For groups A and B: positive baseline food challenge to included allergens
- For groups C and D: negative baseline food challenge to included allergens
You will not qualify if you...
- Presence of other serious illnesses
- History of previous life-threatening anaphylaxis requiring intensive care
- Diagnosis of eosinophilic esophagitis or eosinophilic gastrointestinal disease
- Severe chronic gastroesophageal reflux disease
- Unclear recurrent gastrointestinal complaints
- Low body weight below 2 standard deviations
- Participation in another intervention study if assigned to intervention group
- Severe uncontrolled asthma
- Current medication with biological drugs or oral steroids
AI-Screening
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Trial Site Locations
Total: 1 location
1
Södersjukhuset
Stockholm, Sweden, 11883
Actively Recruiting
Research Team
I
Idun Holmdahl, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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