Clinical Versus Home Introduction of Milk in Children With Non-IgE-mediated Cow's Milk Allergy (ENIGMA)
Cow Milk Allergy, Food Allergy
About this trial
This is an interventional diagnostic trial for Cow Milk Allergy
Eligibility Criteria
Inclusion Criteria: maximum age of eighteen months; suspected to be allergic for cow's milk (based on medical history); Exclusion Criteria: children older than the age of eighteen months; sensitised for cow's milk (i.e. SPT >3mm (in combination with positive control ≥3mm) or specific IgE >0.35 kU/L) patient suffers from acute (i.e. within one hour after cow's milk had been eaten) and moderate-severe IgE-mediated symptoms after ingestion of cow's milk patient suffers from symptoms according to the FPIES criteria after ingestion of cow's milk patient uses beta blockers and/or prednisolone; patient suffers from uncontrolled respiratory symptoms or severe eczema or a chronic condition because of which the patients cannot be included as judged by the treating physician; parents are unable to adequately report the occurrence of possible symptoms (e.g. insufficient language proficiency).
Sites / Locations
- Martini HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Double blind placebo controlled challenge test
Home introduction test
Introduction of cow's milk by means of an adjusted double blind placebo controlled challenge test
Introduction of cow's milk by means of a standardized schedule