Actively Recruiting
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
Eligibility Criteria
You may qualify if you...
- Maximum age of eighteen months
- Suspected allergy to cow's milk based on medical history
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
Trial Site Locations
Total: 1 location
1
Martini Hospital
Groningen, Netherlands
Actively Recruiting
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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