Slow multiallergen oral immunotherapy for young children with food allergies
Infant Food Allergen Oral Immunotherapy (InFO)
This will test whether slowly giving small daily doses of a powder made from many common allergens can safely desensitize children aged 6 months to 3 years with food allergies and help prevent new allergies.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 6 Months to 3 Years |
| Sex | All |
| Sponsor | Karolinska Institutet Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Stockholm) |
| Trial ID | NCT06533462 on ClinicalTrials.gov |
What this trial studies
This randomized, double-blind trial enrolls young children (0.5–3 years) with IgE sensitization and randomizes 80 children who react on baseline food challenge 1:1 to receive either a multiallergen OIT powder (about 200 mg protein of each included food) or placebo with slow up-dosing to a maintenance of three teaspoons daily for two years. Children who do not react at baseline are analyzed in a separate sub-randomized comparison to low-dose multiallergen powder versus placebo. Food challenges are repeated after 1 and 2 years to measure desensitization, and safety monitoring is performed throughout the study. The multiallergen product includes egg, milk, wheat, lentils, soy, peanut and several tree nuts and was developed with the Research Institute of Sweden.
Who should consider this trial
Good fit: Ideal candidates are children aged 0.5–3 years with IgE (>0.1 kUA/L) to at least one of the included foods and a positive baseline food challenge (for the main randomized groups), with written consent from both guardians.
Not a fit: Children with prior life‑threatening anaphylaxis requiring intensive care, eosinophilic gastrointestinal disease, severe uncontrolled asthma, very low body weight, or other serious illnesses are excluded and are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the approach could induce tolerance or durable desensitization to multiple common food allergens in very young children and possibly reduce the development of additional food allergies.
How similar studies have performed: Single-allergen OIT in older children has shown the ability to induce desensitization, but slow multiallergen OIT in very young children is less well studied and is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Stockholm
- Södersjukhuset — Stockholm, Sweden (Recruiting)
Study contacts
- Principal investigator: Caroline Nilsson, MD, PhD — Karolinska Institutet
- Study coordinator: Idun Holmdahl, MD, PhD
- Email: idun.holmdahl@ki.se
- Phone: +46703002279
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.