A randomized controlled trial to investigate the (cost)effectiveness of oral immunotherapy with different allergens in young children with an established food allergy.

Recruiting

Conditions: Food allergie
10001708

Registration Number: NL-OMON51688

Lead Sponsor: Deventer Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 500

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

- (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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Sustained unresponsiveness, defined as passing an exit oral food challenge at 4<br /><br>weeks after discontinuation of the 12 months oral immunotherapy, and<br /><br>uncomplicated consumption of a full dose of the specific food at home, after 6<br /><br>months unrestricted introduction of the specific food into the diet. </p><br>

Secondary Outcome Measures