Actively Recruiting

Phase Not Applicable
Age: 1Month - 18Months
All Genders
NCT05785299

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

Led by Martini Hospital Groningen · Updated on 2024-11-25

120

Participants Needed

1

Research Sites

138 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 1Month - 18Months
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Maximum age of eighteen months
  • Suspected allergy to cow's milk based on medical history
Not Eligible

You will not qualify if you...

  • Children older than eighteen months
  • Sensitization to cow's milk confirmed by skin prick test or specific IgE above thresholds
  • Acute moderate to severe IgE-mediated symptoms occurring within one hour after cow's milk ingestion
  • Symptoms meeting Food Protein-Induced Enterocolitis Syndrome (FPIES) criteria after cow's milk ingestion
  • Current use of beta blockers or prednisolone
  • Uncontrolled respiratory symptoms, severe eczema, or other chronic conditions preventing inclusion as judged by the physician
  • Parents unable to adequately report symptoms such as due to insufficient language proficiency

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Martini Hospital

Groningen, Netherlands

Actively Recruiting

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Research Team

K

Kamps, MD,PhD

CONTACT

V

van der Pluijm, RN

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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