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Active Not Recruiting
NCT06533462
Slow Multiallergen Oral Immunotherapy in Young Children
Conditions: Food Allergy, Oral Immunotherapy for Food Allergy
Sex: All
Ages: 6 Months – 3 Years
Healthy volunteers: No
Phase: NA
Enrollment: 80
Sponsor: Karolinska Institutet
Location: Södersjukhuset Stockholm
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 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.
Eligibility Criteria
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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 \
Source: ClinicalTrials.gov (NCT06533462). StuddyBuddy aggregates publicly available trial information.