About this trial
There are a lot of parents who believe that their child may not tolerate cow's milk because they develop symptoms such as redness of the skin or they may vomit. It is not always easy to find out if these infants should indeed avoid drinking cow's milk or that the symptoms are caused by something else, for instance because they have a viral illness. The goal of the investigators is to find out if cow's milk should be introduced in the hospital or if it can also be advised to perform the introduction at home to determine if an infant can drink cow's milk without developing symptoms. Half of the participants will drink cow's milk in the hospital. This test is performed on two days. On one of the days cow's milk will be offered. On the other day a look-alike substance is offered. The other half of the participants will drink cow's milk at home by starting to drink a little bit of milk and in a few steps drink a normal bottle of cow's milk. The main question is whether both tests can be used to find out if an infant can drink cow's milk without developing symptoms.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
maximum age of eighteen months;
suspected to be allergic for cow's milk (based on medical history);
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Cow's milk
Diagnostic testclinical introduction of cow's milk
Placebo
Diagnostic testclinical introduction of placebo
Home introduction
Diagnostic testhome introduction of cow's milk
Treatment groups
Trial outcomes
Primary outcomes
Number of participants with a positive or negative test
Positive (intolerant) or negative (tolerant) outcome of the introduction test
Secondary outcomes
Regular milk consumption
Milk consumption is based on normal daily intake for age
Percentage and type of reported symptoms
Reported symptoms are classified according to predefined criteria
Healthcare utilisation during the study period
Healthcare utilisation is determined by evaluation of the number of physical and telephone consultations
Sponsors and contacts
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