RecruitingNot Applicable

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

Netherlands120 participantsStarted 2023-10-09

Plain-language 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.

Who can participate

Age range

1 Month – 18 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of participants with a positive or negative test

Timeframe: Determined 1 week after start of the test

Trial details

NCT IDNCT05785299

SponsorMartini Hospital Groningen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06-01

Contact for this trial

Kamps, MD,PhD

31505246900 a.kamps@mzh.nl

View on ClinicalTrials.gov More Cow Milk Allergy trials