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Clinical Trials in the Netherlands / NCT05785299
Recruiting Not applicable

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

NCT05785299 · tracked via the Priya Life Science Netherlands tracker
Phase
Not applicable
Started
2023-10-09
Last updated
2024-11-25

Condition(s) studied

Cow Milk AllergyFood Allergy

Investigational drug(s) / intervention(s)

Cow's milkPlaceboHome introduction

Cow's milk: clinical introduction of cow's milk

Placebo: clinical introduction of placebo

Home introduction: home introduction of cow's milk

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.

Eligibility

Sex
ALL
Min age
1 Month
Max age
18 Months
Healthy volunteers
No
Inclusion Criteria: * maximum age of eighteen months; * suspected to be allergic for cow's milk (based on medical history); Exclusion Criteria: * children older than the age of eighteen months; * sensitised for cow's milk (i.e. SPT \>3mm (in combination with positive control ≥3mm) or specific IgE \>0.35 kU/L) * patient suffers from acute (i.e. within one hour after cow's milk had been eaten) and moderate-severe IgE-mediated symptoms after ingestion of cow's milk * patient suffers from symptoms according to the FPIES criteria after ingestion of cow's milk * patient uses beta blockers and/or prednisolone; * patient suffers from uncontrolled respiratory symptoms or severe eczema or a chronic condition because of which the patients cannot be included as judged by the treating physician; * parents are unable to adequately report the occurrence of possible symptoms (e.g. insufficient language proficiency).

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Martini Hospital Groningen Netherlands Recruiting

More Martini Hospital Groningen trials in the Netherlands

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05785299 on ClinicalTrials.gov ↗ ← All trials in the Netherlands