Food Allergy in ChildrenINFO-DKNCT07899359
Immunotherapy for Curing Toddlers With Severe Food Allergy - a Paradigm Shift From Passive to Active Treatment With Multi-allergen Oral Immunotherapy
A study testing OIT multiallergen powder in people with Food Allergy in Children, run by Odense University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 47 months
- Conditions the study is for
- Food Allergy in Children
- What is being tested?
- OIT multiallergen powder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2027to Dec 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 47 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children referred to Hans Christian Andersen Children's Hospital with a suspicion of food allergy
- age: 6-47 months
- sIgE against one or more of the included 10 allergens > 0.1kU/L
Who cannot join
- Other serious illness
- previous life-threatening anaphylaxis (intensive care)
- eosinophilic gastrointestinal disease
- severe chronic gastro-esophageal reflux disease
- unclear recurrent GI complaints
- low body weight <2SD
Show all 9Show fewer
- participation in another intervention study if included in intervention group -severe uncontrolled asthma
- spontaneous urticaria
- medication with biological drugs within the past year or oral steroids
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Immunotherapy for Curing Toddlers With Severe Food Allergy (InFO-DK)
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).
Read more
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.
Read the detailed description
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:
- Tolerance to cumulative dose of 900 mg protein of each food (as above), evaluated after two years in group A and B
- Changes in immunological markers (specific IgE, IgG, T-cell populations, plasma proteins, feces microbiota, and metabolites etc.) in relation to interventions
- Changes in eczema and asthma status in relation to interventions
- Changes in quality of life in relation to interventions.
- Conditions
- Food Allergy in Children
- Being tested
- OIT multiallergen powder, Placebo powder
- Keywords
- food allergy, OIT, oral immunotherapy
- Medical subject headings
- Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OIT multiallergen powderDietary supplement
low-dose multiallergen (10 allergens) powder
Placebo powderDietary supplement
gluten-free oatmeal
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Allergic children, Multiallergen OIT Receives: Dietary Supplement: OIT multiallergen powder |
| Group B | Placebo comparator | Allergic children, placebo powder Receives: Dietary Supplement: Placebo powder |
| Group C | Active comparator | Non-allergic children, low-dose multiallergen powder Receives: Dietary Supplement: OIT multiallergen powder |
| Group D | Placebo comparator | Non-allergic children, low-dose placebo powder Receives: Dietary Supplement: Placebo powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (4)
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.
Measured: 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
Measured: 2 years
comorbidities
Number of children with eczema and asthma in all groups after 0,1 and 2 years
Measured: 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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start1 Jan 2027 (estimated)
- Primary completionDec 2032 (estimated)
- Study completionDec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food Allergy in ChildrenStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Josefine Gradman, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07899359
- Sponsor's protocol ID
- INFO-DK
- Acronym
- INFO-DK
- Status last verified
- Oct 2026
- First submitted
- 15 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no actual plan to make de-identified individual participant data (IPD) collected in this study available to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunotherapy for Curing Toddlers With Severe Food Allergy (InFO-DK)
- ClinicalTrials.gov ID
- NCT07899359
- Acronym / sponsor ID
- INFO-DK / INFO-DK
- Conditions
- Food Allergy in Children
- Keywords
- food allergy, OIT, oral immunotherapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- Dec 2032 (estimated)
- Study completion
- Dec 2032 (estimated)
- First posted
- 27 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Tolerance to cumulative dose of 900 mg protein of each food (as above), evaluated after two years in group A and B
- Changes in immunological markers (specific IgE, IgG, T-cell populations, plasma proteins, feces microbiota, and metabolites etc.) in relation to interventions
- Changes in eczema and asthma status in relation to interventions
- Changes in quality of life in relation to interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Dietary Supplement: OIT multiallergen powderAllergic children, Multiallergen OIT |
| Group B | Placebo comparator | Dietary Supplement: Placebo powderAllergic children, placebo powder |
| Group C | Active comparator | Dietary Supplement: OIT multiallergen powderNon-allergic children, low-dose multiallergen powder |
| Group D | Placebo comparator | Dietary Supplement: Placebo powderNon-allergic children, low-dose placebo powder |
Who may qualify
- Ages
- 6 to 47 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- children referred to Hans Christian Andersen Children's Hospital with a suspicion of food allergy
- age: 6-47 months
- sIgE against one or more of the included 10 allergens > 0.1kU/L
Key exclusion criteria (9 listed)
- Other serious illness
- previous life-threatening anaphylaxis (intensive care)
- eosinophilic gastrointestinal disease
- severe chronic gastro-esophageal reflux disease
- unclear recurrent GI complaints
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OIT multiallergen powderlow-dose multiallergen (10 allergens) powder | Dietary supplement | Group A, Group C |
| Placebo powdergluten-free oatmeal | Dietary supplement | Group B, Group D |
Primary outcome
Number of patients with tolerance to 900 mg protein at a food challenge in the clinic after 1 year in alle groups.
Time frame: 1 year
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.
4 secondary outcomes
Number of children with tolerance to 900 mg protein at a food challenge in the clinic after two years in group A and B
Time frame: 2 years
Immunological biomarkers
Time frame: 2 years
comorbidities
Time frame: 2 years
Difference in Quality of life between groups measured by a questionnaire
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: No. There is no actual plan to make de-identified individual participant data (IPD) collected in this study available to other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing OIT multiallergen powder in people with Food Allergy in Children, run by Odense University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Josefine Gradman, MD, PhD (+45 24608127, josefine.gradman@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with tolerance to 900 mg protein at a food challenge in the clinic after 1 year in alle groups. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.