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Clinical Versus Home Introduction of Milk in Children with Non-IgE-mediated Cow's Milk Allergy
Sponsor: Martini Hospital Groningen
Summary
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.
Official title: Evaluation of the Outcome of Clinical or Home Introduction of Milk in Children with Non-IgE-mediated Cow's Milk Allergy (ENIGMA Trial)
Key Details
Gender
All
Age Range
1 Month - 18 Months
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2023-10-09
Completion Date
2026-06-01
Last Updated
2024-11-25
Healthy Volunteers
No
Conditions
Interventions
Cow's milk
clinical introduction of cow's milk
Placebo
clinical introduction of placebo
Home introduction
home introduction of cow's milk
Locations (1)
Martini Hospital
Groningen, Netherlands