NCT06533462 Randomized Controlled Trial of Slow Multiallergen Oral Immunotherapy in Young Children
| NCT ID | NCT06533462 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Karolinska Institutet |
| Condition | Food Allergy |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2024-11-08 |
| Primary Completion | 2027-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2024-11-08 with a primary completion date of 2027-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 0.5-3 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. * 80 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 Criteria: * 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.
Contact & Investigator
Caroline Nilsson, MD, PhD
PRINCIPAL INVESTIGATOR
Karolinska Institutet
Frequently Asked Questions
Who can join the NCT06533462 clinical trial?
This trial is open to participants of all sexes, aged 6 Months or older, up to 3 Years, studying Food Allergy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06533462 currently recruiting?
Yes, NCT06533462 is actively recruiting participants. Contact the research team at idun.holmdahl@ki.se for enrollment information.
Where is the NCT06533462 trial being conducted?
This trial is being conducted at Stockholm, Sweden.
Who is sponsoring the NCT06533462 clinical trial?
NCT06533462 is sponsored by Karolinska Institutet. The principal investigator is Caroline Nilsson, MD, PhD at Karolinska Institutet. The trial plans to enroll 80 participants.