Clinical Trial

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

Study acronym: ENIGMA
Recruiting
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Record status
This record was last updated November 25, 2024 (before its estimated June 1, 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2023-03-24; most recent amendment 2024-11-21.
Status change: Not Yet Recruiting → Recruiting 2023-10-23
Trial Details
NCT Number NCT05785299
Lead Sponsor Martini Hospital Groningen
Conditions Cow Milk Allergy, Food Allergy
Enrollment 120 participants
Start Date 2023-10-09
Primary Completion 2026-06-01 (estimated)
Study Completion 2026-06-01 (estimated)
Updated on ClinicalTrials.gov 2024-11-25