Food allergy
Conditions
Interventions
Children who are enrolled in the ORKA study start with the OIT (daily intake of
a small amount of food for which the patient is allergic) within about 2 weeks
after the provocation test. After the m
Sponsors
Deventer Ziekenhuis
Eligibility
Age
No minimum to 1 Years
Inclusion criteria
Inclusion criteria: • Children with an age of 9 to 24 months. • A proven food allergy (positive provocation and sensitization demonstrated by a skin prick test> 3mm and / or sIgE> 0.35kU / L) for chicken egg, peanut, cow's milk, cashewnut, hazelnut, walnut and/or one of the more rare allergens (as soja, pits and seeds (sesameseed and pine nut) and wheat). • Assessment of the presence of other food allergies (standard care) by introduction in the diet and / or the determination of sensitization. From the mentioned allergens, introduction into the diet or the diagnosis food allergy has been made. • Written permission (signed informed consent form) from both parents / guardian for participation in the study.
Exclusion criteria
Exclusion criteria: • Uncontrolled toddler asthma and / or frequent exacerbations (viral wheezing) defined as toddlers who have been admitted to hospital > 1x in the past six months because of these complaints. • Uncontrolled eczema. • Severe gastrointestinal complaints such as gastroesophageal reflux disease, where an underlying disease such as eosinophilic esophagitis (EoE) cannot be excluded. • Active EoE. • Mastocytosis (also cutaneous). • Psycho-social problems in the family that may be a barrier to a good daily performance of long-term therapy. • Inability of parents to follow instructions, to recognize allergic reactions or to administer emergency medication. • Participation in any other intervention study at the time of the ORKA study, with the exception of studies on guided early introduction of high-allergenic nutrition.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety based on the number of anaphylactic reactions that occur within 2 hours after administration of the food product. Feasibility as assessed by both parents and doctors. Effectiveness measured as the number of children with long-term tolerance (SU): a negative provocation test 4 weeks after the discontinuation of the OIT and a problem-free introduction of the food allergen in the diet, and the number of children with remission: a negative food provocation at least 2 years after cessation of OIT, with strict avoidance of the specific food allergen in in the 12 weeks preceding the provocation test. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Number of children with sustained unresponsiveness: a negative food challenge 4 weeks after discontinuation of OIT. • Number of children with a problem-free introduction of the food allergen in the diet 6 months after discontinuation of the OIT. • Number of children with food allergy remission: a negative food provocation at least 2 years after cessation of OIT, with strict avoidance of the specific food allergen in the 12 weeks preceding the food provocation | — |
Countries
Netherlands
Outcome results
None listed