Oral immunotherapy in young children diagnosed with food allergy

Recruiting

Conditions: Food allergy

Registration Number: NL-OMON20790

Lead Sponsor: Deventer Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 60

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 slgÉ> 0.35kU / L) for chicken egg, peanut, cashew nut, hazelnut and / or 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

• Uncontrolled viral wheezing, defined as 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
Safety based on the number of anaphylactic reactions that occurs within 2 hours after administration of the food product. Feasibility<br>as assessed by both parents and doctors.

Secondary Outcome Measures

Name	Time	Method
Effectiveness measured as the number of children with long-term tolerance (SU): a<br>negative food challenge 4 weeks after the discontinuation of the OIT.