Introducing cow's milk to children with suspected allergies

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to determine whether introducing cow's milk in a hospital setting or at home is more effective for infants suspected of having non-IgE-mediated cow's milk allergy. Participants will be randomly assigned to either a double-blind placebo-controlled food challenge (DBPCFC) in the hospital or a gradual home introduction of cow's milk. The study will assess the outcomes of both methods to see if they can safely identify children who can tolerate cow's milk without developing symptoms. The goal is to improve the diagnostic process for cow's milk allergy in infants.

Why it matters

Who can join: the full rules

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).

Where it's running

• Martini Hospital
  Groningen, Netherlands Recruiting

Study contacts

• Principal investigator: Kamps, MD, PhD — Martini Ziekenhuis Groningen
• Study coordinator: Kamps, MD,PhD
• Email: a.kamps@mzh.nl
• Phone: 31505246900

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.