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

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

Inclusion Criteria4

  • 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.
  • 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 Criteria10

  • 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DIETARY_SUPPLEMENTMultiallergen powder

OIT multiallergen powder.


Locations(1)

Södersjukhuset

Stockholm, Sweden

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06533462