Table 2 Diagnosis of food allergy for the determination of endpoints
Procedure | Positive result |
|---|---|
Oral food challenge (OFC) | OFC outcome is positive if objective symptoms of immediate type allergic reactions occur after any administered dose. (OFC outcome is negative if no objective symptoms of immediate type allergic reactions occur after ingestion of any administered dose.) |
Allergen-specific IgE (sIgE) | sIgE ≥ 0.1 kU/l |
Skin prick test (SPT) | Wheel size ≥ 3 mm |
Immediate-type allergic reaction due to accidental exposure | Parent-reported objective symptoms of immediate type allergic reactions upon accidental exposure to the interventional food(s) during the interventional period |