An interventional study of OIT multiallergen powder and Placebo powder in Food Allergy in Children, sponsored by Odense University Hospital. Not yet recruiting. Open to participants aged 6 Months to 47 Months. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Odense University Hospital · Not applicable, Interventional, and Treatment
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.
Today, there is no established curative treatment for food allergies, and those affected must avoid the food that triggers symptoms. The most studied method is oral immunotherapy (OIT) which have mainly been carried out on children >4 years of age. The OIT method implies that the allergic individual eats initially very low doses and gradually increasing amounts of the allergen until a maintenance dose is reached. The treatment aims to induce desensitization or tolerance to the allergen.
Intervention: The intervention substance is a powder containing a prespecified amount of 10 allergens (egg, milk, wheat, lentils, soy, walnut, peanut, hazelnut, cashew, almond), which are the most triggering allergens in children. The product is developed in cooperation with Research Institute of Sweden (RISE).
Clinical randomized controlled (1:1) blinded interventional trial (RCT) with 2 interventions arms (group A and B). A sub-analysis will be performed of the children not reacting to the baseline challenge (group C and D).
Group A: Children with food allergy (sensitization and positive baseline challenge), receiving multiallergen powder OIT, slow up-dosing until 3 teaspoons of the multiallergen powder is reached daily. Food challenge will be performed after 1 and 2 years. 2 years treatment.
Group B: Children with food allergy (sensitization and positive baseline challenge), receiving OIT with placebo (gluten-free oatmeal) followed by maintenance, in 1 year. After 1 year, children in Group B will be offered a cross-over receive 1 year of active OIT treatment. Food challenge will be performed after 1 and 2 years.
Group C and D: sensitized children with a negative baseline challenge will be randomized 1:1 for treatment with multiallergen powder or placebo powder in a lower amount, 1 teaspoon daily and can introduce food in accordance with Danish guidelines. After one year a food challenge will be performed.
Selection for group A to D: All children 0.5-3 years of age referred to H.C. Andersen Children's Hospital, Odense University Hospital due to suspected food allergy to one or more of the 10 included allergens and with a specific immunoglobulin E (IgE) >0.1 kUA/L, are eligible as possible study participants.
Inclusion groups A and B: Eighty children, group A (n=40) and group B (n=40) also need a positive baseline food challenge.
Inclusion groups C and D: Children with a negative food challenge (number is not determined)
Primary outcome: Tolerance to 900 mg protein, cumulative dose, of each of the 10 included allergens at the food challenge after one year of OIT treatment or placebo.
Secondary outcomes:
348 studies on the registry are indexed under Food Hypersensitivity; 90 are open to participants now.
This study's planned enrollment of 80 is above the median of 60 across 219 interventional studies indexed under Food Hypersensitivity.
Browse Food Hypersensitivity studies →Odense University Hospital is the lead sponsor of 478 studies on the registry; 109 are open to participants now.
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Exclusion Criteria:
Allergic children, Multiallergen OIT
Dietary Supplement: OIT multiallergen powder
Allergic children, placebo powder
Dietary Supplement: Placebo powder
Non-allergic children, low-dose multiallergen powder
Dietary Supplement: OIT multiallergen powder
Non-allergic children, low-dose placebo powder
Dietary Supplement: Placebo powder
low-dose multiallergen (10 allergens) powder
gluten-free oatmeal
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.
Time frame: 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
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.
Time frame: 2 years
Immunological biomarkers
Changes in immunological markers (specific IgE, IgG, T-cell populations, plasma proteins, feces microbiota, and metabolites etc.) in relation to interventions
Time frame: 2 years
comorbidities
Number of children with eczema and asthma in all groups after 0,1 and 2 years
Time frame: 2 years
Difference in Quality of life between groups measured by a questionnaire
In all groups, the parents will fullfill the questionnaire FAQLQ-PF after 0, 1 and 2 years to compare QoL. The hypothesis is that the intervention is associated with a higher FAQLQ-PF-score than the placebo group.
Time frame: 2 years
No study locations are listed for this record.
Plan to share: No — There is no actual plan to make de-identified individual participant data (IPD) collected in this study available to other researchers
No publications or documents are linked to this record.
Start is estimated for Jan 2027; primary completion for Dec 2032, 71 months later.
Of 83 non-industry interventional studies with no phase under Food Hypersensitivity, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 50. This study's planned 71 months is above that.
Counting every sponsor, half of 86 studies reached it within 29 months; a quarter within 13 and three quarters within 44.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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