Food allergie
Conditions
Interventions
1-year low-dose oral immunotherapy (daily 300 mg allergenic protein) compared
to strict avoidance in the control group.
Sponsors
Deventer Ziekenhuis
Eligibility
Age
No minimum to 11 Years
Inclusion criteria
Inclusion criteria: - 9 to 30 months of age at inclusion. - an IgE-mediated food allergy to peanut, cashew, hazelnut, walnut, cow*s milk and/or hen*s egg as proven by sensitization to the specific allergen (sIgE > 0.35kU/l) and a positive oral food challenge. - The fore-mentioned allergens are introduced into the diet of the child (the child is tolerant for the specific allergen(s)), or the child is diagnosed with a food allergy for the specific allergen(s). - Informed consent is given by parent(s) or guardian(s).
Exclusion criteria
Exclusion criteria: - (suspected) eosinophilic oesophagitis - uncontrolled asthma/ viral wheeze. - the inability of parents to follow instructions, recognize allergic reactions or administer emergency medication. - participation in any other intervention study at the time of the OIT study, with the exception of studies on guided early introduction of highly allergenic foods.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sustained unresponsiveness, defined as passing an exit oral food challenge at 4 weeks after discontinuation of the 12 months oral immunotherapy, and uncomplicated consumption of a full dose of the specific food at home, after 6 months unrestricted introduction of the specific food into the diet. | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life, costs/impact of food allergy and treatment, immunological parameters (blood tests), adherence to treatment. | — |
Countries
Netherlands
Outcome results
None listed