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NCT04599946Active, not recruiting

Goat Infant Formula Feeding and Eczema (the GIraFFE Study)

Effects of Infant Feeding With Goat Milk Formula or Cow Milk Formula on Atopic Dermatitis

Source: ClinicalTrials.gov · Last updated 27 Aug 2026

Brief summary (registry, in English)

To determine the relative risk of developing atopic dermatitis in infants fed a study formula based on whole goat milk compared to infants a study formula based on cow milk protein.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
2132 (actual)
First submitted
5 Oct 2020
Start date
8 Jan 2021
Primary completion date
28 Aug 2024
Lead sponsor
Dairy Goat Co-operative (N.Z.) Limited
NCT number
NCT04599946

What you commit to

  • Study type: Interventional
  • Participants enrolled: 2132
  • From 8 Jan 2021 to the primary completion date, 28 Aug 2024
  • 12 sites in 3 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other illness

  • Diagnosed disorder considered to interfere with nutrition, growth or development of the immune system
  • Cow milk allergy or intolerance

Other

  • Participation of the child in any other interventional trial or participation of the mother in any intervention trial with child follow-up
  • Institutionalized infant

Who the study is looking for

  • 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

Age in the registry: 0 days to 90 days · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (12)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Dr. von Hauner Children's Hospital, LMU University Hospital Munich
Coordinator of this site? Confirm its status
MunichGermanyUnknown status
Unit of Pediatric Gastroenterology and Nutrition, Torrecardenas University Hospital
Coordinator of this site? Confirm its status
AlmeríaSpainUnknown status
EURISTIKOS Excellence Centre for Paediatric Research, University of Granada
Coordinator of this site? Confirm its status
GranadaSpainUnknown status
Department of Neonatology, Hospital Universitario La Paz
Coordinator of this site? Confirm its status
MadridSpainUnknown status
Hospital Universitari Sant Joan de Reus
Coordinator of this site? Confirm its status
ReusSpainUnknown status
Hospital Universitari Joan XXIII de Tarragona
Coordinator of this site? Confirm its status
TarragonaSpainUnknown status
INCLIVA Health Research Institute
Coordinator of this site? Confirm its status
ValenciaSpainUnknown status
Hospital Clinico Universitario Lozano Blesa, Instituto de investigacion Sanitaria de Aragon
Coordinator of this site? Confirm its status
ZaragozaSpainUnknown status
Wojewodzki Specjalistyczny Szpital Dzieciecy
Coordinator of this site? Confirm its status
OlsztynPolandUnknown status
Karol Jonscher's University Hospital
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PoznanPolandUnknown status
Medical College of Rzeszow University
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RzeszówPolandUnknown status
Children's Memorial Health Institute
Coordinator of this site? Confirm its status
WarsawPolandUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.