Food Allergy
Conditions
Interventions
Group 1: Active group (verum):
Participants receive a rusk-like biscuit powder with very small amounts of the food(s) the child is sensitized to (hen’s egg, cow’s milk, peanut and/ or hazelnut) once
Sponsors
Charité Universitätsmedizin
Eligibility
Sex/Gender
All
Age
8 Months to 4 Years
Inclusion criteria
Inclusion criteria: • Children, age 8 months to 4 years • Sensitization (specific IgE =0.1 kU/l and/or Skinpricktest wheal size =3mm) against hen´s egg, cow´s milk, hazelnut and/or peanut • Scheduled oral food challenge 3-6 months after enrollment • Signed informed consent of parents
Exclusion criteria
Exclusion criteria: • previous consumption of the food the infant is sensitized to (hen´s egg, peanut, cow´s milk and/or hazelnut) in relevant amounts (and an OFC is deemed not necessary to determine the clinical relevance of the sensitization) • doctor´s diagnosed wheat allergy • severe diseases (e.g. cardiac, congenital) • twin sibling of a study participant • participation in another interventional trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| IgE-mediated food allergy to the food, which the child was sensitized to at baseline (hen’s egg, cow’s milk, peanut, or hazelnut), after 3-6 months (plus max. 3 months in case of postponed oral food challenges due to important reasons, such as recurrent infections) of intervention. For polyvalent sensitized children, a ‘primary food allergen’ will be determined randomly at enrolment which will be used to define the primary endpoint. | — |
Secondary
| Measure | Time frame |
|---|---|
| The following secondary endpoints will be assessed after 3-6 months (plus max. 3 months in case of postponed oral food challenges due to important reasons, such as recurrent infections) of intervention: • IgE-mediated food allergy determined by oral food challenge (plus sIgE =0.1 OR positive Skinpricktest) to the ‘primary food allergen’ • IgE-mediated food allergy determined by an immediate type allergic reaction due to accidental exposure (plus sIgE =0.1 OR positive Skinpricktest) to the ‘primary food allergen’ • IgE-mediated food allergy determined by oral food challenge (plus sIgE =0.1 OR positive SPT) OR an immediate type allergic reaction due to an accidental exposure (plus sIgE =0.1 OR positive Skinpricktest) to either: • hen’s egg • cow´s milk • peanut • hazelnut (for children sensitized to the respective allergen at baseline) • Occurrence (frequency and severity) of immediate type allergic symptoms • Occurrence of gastrointestinal symptoms • Multiple food allergies • Number of food allergies • Change of SCORAD (in subjects with eczema) • Change of EASIscore (in subjects with eczema) • Wheezing • (Change in) allergen-specific IgE to hen´s egg, cow´s milk. peanut and/or hazelnut • (Change in) Wheal-size measured by skin prick testing to hen´s egg, cow´s milk. peanut and/or hazelnut | — |
Countries
Germany
Contacts
Public ContactBirgit Kalb
Charité Universitätsmedizin
Outcome results
None listed