Clinical Versus Home Introduction of Milk in Children with Non-IgE-mediated Cow's Milk Allergy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-18
SponsorMartini Hospital Groningen

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Cow's milk

    Diagnostic test

    clinical introduction of cow's milk

  • Placebo

    Diagnostic test

    clinical introduction of placebo

  • Home introduction

    Diagnostic test

    home introduction of cow's milk

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Double blind placebo controlled challenge testActive comparator 2 interventions
Group B: Home introduction testActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of participants with a positive or negative test

Positive (intolerant) or negative (tolerant) outcome of the introduction test

Time frame
Determined 1 week after start of the test

Secondary outcomes

1

Regular milk consumption

Milk consumption is based on normal daily intake for age

Time frame
Determined 6 weeks after completion of the test
2

Percentage and type of reported symptoms

Reported symptoms are classified according to predefined criteria

Time frame
Determined 6 weeks after completion of the test
3

Healthcare utilisation during the study period

Healthcare utilisation is determined by evaluation of the number of physical and telephone consultations

Time frame
Determined 6 weeks after completion of the test

Other outcomes

Sponsors and contacts

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