NCT07899359|Not Yet Recruiting
Immunotherapy for Curing Toddlers With Severe Food Allergy - a Paradigm Shift From Passive to Active Treatment With Multi-allergen Oral Immunotherapy
INFO-DK
Loading search results
INFO-DK
Sponsor study identifier
interventional
80
0 countries
N/A
Study Start
January 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
December 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 15, 2026
Actual (reported)October 27, 2026
Actual (reported)January 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Number of patients with tolerance to 900 mg protein at a food challenge in the clinic after 1 year in alle groups.
The outcome of a food challenge is dichotome: tolerance to 900mg or not (= negative or positive provocation) A food challenge is a standardised procedure: Increasing amounts of protein powder is given to the child every 30 minutes until the 900 mg is reached (= tolerance) or until the child has an objective allergic reaction (=positiv food challenge). An objective allergic reaction is a clinical diagnosis. In case of an allergic reaction, the cumulative dose of ingested allergen and the observed symptoms are registered.
1 year
Number of children with tolerance to 900 mg protein at a food challenge in the clinic after two years in group A and B
2 years
Immunological biomarkers
2 years
comorbidities
2 years
Difference in Quality of life between groups measured by a questionnaire
2 years
Allergic children, Multiallergen OIT
Allergic children, placebo powder
Non-allergic children, low-dose multiallergen powder
low-dose multiallergen (10 allergens) powder
First Submitted
October 15, 2026
First Posted
October 27, 2026
Study Start
January 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Non-allergic children, low-dose placebo powder
Contact the study team to confirm eligibility.
Primary Completion
December 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 27, 2026
Record last verified: 2026-10
There is no actual plan to make de-identified individual participant data (IPD) collected in this study available to other researchers
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: