Infant Food Allergen Oral Immunotherapy (InFO)

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 6 months
Maximum Age: 3
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Sweden
Södersjukhuset
RECRUITING
Stockholm
Contact Information
Primary
Idun Holmdahl, MD, PhD
idun.holmdahl@ki.se
+46703002279
Time Frame
Start Date: 2024-11-08
Estimated Completion Date: 2027-12
Participants
Target number of participants: 80
Treatments
Active_comparator: Group A: Allergic children - Multiallergen OIT
Children with food allergy receiving multiallergen powder OIT. Multiallergen food challenge is done before randomization and one and two years after inclusion. OIT multiallergen powder with slow up-dosing until 3 teaspoons of the multiallergen powder is reached and taken daily. 2 years treatment.~Number = 40 patients~Intervention: multiallergen powder
No_intervention: Group B: Allergic children - Placebo powder
Children with food allergy receiving OIT with placebo powder (gluten-free oatmeal). Multiallergen food challenge is done before randomization and one and two years after inclusion.~Number = 40 patients
Active_comparator: Group C: Non-allergic children - low dose multiallergen powder
Children not reacting to the baseline challenge who will be randomized to eat a low dose of the multiallergen powder, 1 teaspoon daily. Multiallergen food challenge is done before randomization and one year after inclusion. 1 year treatment.~Number = X~Intervention: Multiallergen powder
No_intervention: Group D: Non-allergic children - placebo powder
Children not reacting to the baseline challenge who will be randomized to eat placebo powder (gluten-free oatmeal) and no specific advice.~Number= X
Related Therapeutic Areas
Sponsors
Leads: Karolinska Institutet

This content was sourced from clinicaltrials.gov