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Slow Multiallergen Oral Immunotherapy in Young Children

Study acronym: InFO
StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Enrollment closed, study ongoing Show 7 more changesShow less
    • Study completion pushed from Dec 2027 to Dec 2029
    • Primary completion date: Aug 2027 to Sep 2027
    • Eligibility criteria expanded, about 14 words
    • Secondary endpoints: details revised at 7 of 7 entries
    • Study description expanded, about 51 words
    • Site details revised
    • Study title shortened, about 4 words
  2. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Aug 2024 to Nov 8, 2024
    • Study title expanded, about 6 words
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06533462
Lead Sponsor Karolinska Institutet
Conditions
(from sponsor)		 Food Allergy, Oral Immunotherapy for Food Allergy
Related terms Food Hypersensitivity
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov