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ACTIVE NOT RECRUITING
NCT06533462
NA

Slow Multiallergen Oral Immunotherapy in Young Children

Sponsor: Karolinska Institutet

View on ClinicalTrials.gov

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.

Official title: Infant Food Allergen Oral Immunotherapy (InFO)

Key Details

Gender

All

Age Range

6 Months - 3 Years

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2024-11-08

Completion Date

2029-12

Last Updated

2026-09-24

Healthy Volunteers

No

Interventions

DIETARY_SUPPLEMENT

Multiallergen powder

OIT multiallergen powder.

Locations (1)

Södersjukhuset

Stockholm, Sweden