Randomized Controlled Trial of Slow Multiallergen Oral Immunotherapy in Young Children
Recruiting now · Not applicable · Has a placebo group
Conditions studied: Food Allergy, Oral Immunotherapy for Food Allergy
In brief
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.
Key facts
- Study ID
- NCT06533462
- Run by
- Karolinska Institutet
- People needed
- 80
- Starts
- 2024-11-08
- Expected to finish
- 2027-12-01
- Last updated by the study team
- 2025-09-16
Who can join
Age: 1 and older, up to 3. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 0.5-3 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.
You may not qualify if…
- 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.
Where it is running
- Södersjukhuset — Stockholm, Sweden (enrolling)
Full record on ClinicalTrials.gov
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