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RECRUITING
NCT05785299
NA

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

Sponsor: Martini Hospital Groningen

View on ClinicalTrials.gov

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

Interventions

DIAGNOSTIC_TEST

Cow's milk

clinical introduction of cow's milk

DIAGNOSTIC_TEST

Placebo

clinical introduction of placebo

DIAGNOSTIC_TEST

Home introduction

home introduction of cow's milk

Locations (1)

Martini Hospital

Groningen, Netherlands