RecruitingNot ApplicableNCT06533462

Randomized Controlled Trial of Slow Multiallergen Oral Immunotherapy in Young Children

Infant Food Allergen Oral Immunotherapy (InFO)


Sponsor

Karolinska Institutet

Enrollment

80 participants

Start Date

Nov 8, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 6 MonthsMax Age: 3 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Multiallergen powder for people with food allergy and oral immunotherapy for food allergy. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTMultiallergen powder

OIT multiallergen powder.


Locations(1)

Södersjukhuset

Stockholm, Sweden

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NCT06533462


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