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Can a switch to goat milk formula prevent baby eczema?

NCT ID NCT04599946

Prevention Sponsor: Dairy Goat Co-operative (N.Z.) Limited Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time

Summary

This trial compares two types of infant formula to see if one lowers the chance of developing eczema, also called atopic dermatitis. Researchers will enroll over 2,000 healthy full-term babies and feed them either a formula made from whole goat milk or one made from cow's milk. They will track how many babies in each group develop eczema by 12 months of age, with follow-up at 24 and 60 months. The goal is to learn whether the type of formula in early life influences allergy risk.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Infant formula made from whole goat milk
What this could lead to
If goat milk formula lowers the risk of eczema, it could offer parents a simple dietary choice to help prevent this common skin condition in babies.
What could go wrong
The trial is early and results may show no difference between formulas. Also, eczema risk depends on many genetic and environmental factors, so formula choice alone may not be decisive.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

2,132 people

The number who actually took part.

Started

Jan 2021

Expected to finish

Sep 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

0 to 90 days

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Having obtained written informed consent (signed and dated) of the child's parent(s)/caregiver(s), indicating that the child's parent(s)/caregiver(s) has/have been informed of all pertinent aspects of the study * Born full term (≥37 weeks +0 days and ≤ 41 weeks +6 days of gestation) * Age at enrolment \< 3 months of age (\<90 days) * Birth weight ≥2.5 kg and ≤4.5 kg * Born from a singleton pregnancy * Child's parent(s)/caregiver(s) is/are of legal age of consent * The child's parent(s)/caregiver(s) have sufficient local language skills to understand the study information, the informed consent, and to comply with the study procedure * The child's parent(s)/caregiver(s) is/are willing and deemed able to fulfil the requirements of the study protocol and procedures * Mother has expressed the intention to partially (in combination with breastfeeding) or fully formula-feed Exclusion Criteria: * Diagnosed disorder considered to interfere with nutrition, growth or development of the immune system * Participation of the child in any other interventional trial or participation of the mother in any intervention trial with child follow-up * Infant has a doctor's diagnosis of atopic dermatitis or a severe widespread skin condition prior to randomization that would make the detection or assessment of atopic dermatitis difficult * Infant has consumed an infant formula for more than 4 weeks prior to enrolment * Cow milk allergy or intolerance * Institutionalized infant

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Conditions

The condition(s) this trial relates to.

atopic eczema prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Child development Dermatitis, atopic Eczema, infantile Infant development

Contacts and locations

Locations

  • Children's Memorial Health Institute

    Warsaw, Poland

  • Department of Neonatology, Hospital Universitario La Paz

    Madrid, Spain

  • Dr. von Hauner Children's Hospital, LMU University Hospital Munich

    Munich, Germany

  • EURISTIKOS Excellence Centre for Paediatric Research, University of Granada

    Granada, Spain

  • Hospital Clinico Universitario Lozano Blesa, Instituto de investigacion Sanitaria de Aragon

    Zaragoza, Spain

  • Hospital Universitari Joan XXIII de Tarragona

    Tarragona, Spain

  • Hospital Universitari Sant Joan de Reus

    Reus, Spain

  • INCLIVA Health Research Institute

    Valencia, Spain

  • Karol Jonscher's University Hospital

    Poznan, Poland

  • Medical College of Rzeszow University

    Rzeszów, Poland

  • Unit of Pediatric Gastroenterology and Nutrition, Torrecardenas University Hospital

    Almería, Spain

  • Wojewodzki Specjalistyczny Szpital Dzieciecy

    Olsztyn, Poland

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