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

NCT05785299 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2024-11-25

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • Martini Hospital Groningen

    lead OTHER

Principal Investigators

  • Kamps, MD, PhD · Martini Ziekenhuis Groningen

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Month
Max Age
18 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-09
Primary Completion
2026-06-01
Completion
2026-06-01

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05785299 on ClinicalTrials.gov