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

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Cow Milk Allergy, Food Allergy

In brief

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.

Key facts

Study ID

NCT05785299

Run by

Martini Hospital Groningen

People needed

120

Starts

2023-10-09

Expected to finish

2026-06-01

Last updated by the study team

2024-11-25

Who can join

Age: 0 and older, up to 2. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• maximum age of eighteen months;
• suspected to be allergic for cow's milk (based on medical history);

You may not qualify if…

• 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).

Where it is running

• Martini Hospital — Groningen, Netherlands (enrolling)

Full record on ClinicalTrials.gov

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