Introducing cow's milk to children with suspected allergies

Evaluation of the Outcome of Clinical or Home Introduction of Milk in Children with Non-IgE-mediated Cow's Milk Allergy (ENIGMA Trial)

This study is testing whether introducing cow's milk to babies suspected of having a milk allergy at home or in the hospital works better to see if they can safely tolerate it.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 1 Month to 18 Months
• Sex: All
• Sponsor: Martini Hospital Groningen (Academic / other)
• Locations: 1 site (Groningen)
• Trial ID: NCT05785299 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are infants up to eighteen months old who are suspected of having a cow's milk allergy based on their medical history.

Not a fit: Patients who are older than eighteen months or have confirmed sensitization to cow's milk will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a safer and more convenient method for diagnosing cow's milk allergy in infants.

How similar studies have performed: While there is limited data on similar approaches, the study aims to address a significant gap in the diagnosis of non-IgE-mediated cow's milk allergy, making it a novel approach.

Eligibility criteria

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 this trial is running

Groningen

• Martini Hospital — Groningen, Netherlands (Recruiting)

Study contacts

• Principal investigator: Kamps, MD, PhD — Martini Ziekenhuis Groningen
• Study coordinator: Kamps, MD,PhD

Conditions Cow Milk Allergy; Food Allergy