An explorative intervention study to investigate the feasibility and safety of oral immunotherapy with different allergens in young children diagnosed with food allergy.
- Conditions
- Food allergy10001708
- Registration Number
- NL-OMON49735
- Lead Sponsor
- Deventer Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 240
• 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.
• 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Safety based on the number of anaphylactic reactions that occurs within 2 hours<br /><br>after administration of the food product. Feasibility as assessed by both<br /><br>parents and doctors. Effectiveness measured as the number of children with<br /><br>long-term tolerance (SU): a negative food challenge 4 weeks after the<br /><br>discontinuation of the OIT and a problem-free introduction of the food allergen<br /><br>in the diet.</p><br>
- Secondary Outcome Measures
Name Time Method <p>• Number of children with sustained unresponsiveness: a negative food challenge<br /><br>4 weeks after discontinuation of OIT.<br /><br>• Number of children with a problem-free introduction of the food allergen in<br /><br>the diet 6 months after discontinuation of the OIT.</p><br>