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
- Diseases
- Atopic dermatitis (eczema)
- 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
Sites (12)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dr. von Hauner Children's Hospital, LMU University Hospital Munich Coordinator of this site? Confirm its status | Munich | Germany | Unknown status |
| Unit of Pediatric Gastroenterology and Nutrition, Torrecardenas University Hospital Coordinator of this site? Confirm its status | Almería | Spain | Unknown status |
| EURISTIKOS Excellence Centre for Paediatric Research, University of Granada Coordinator of this site? Confirm its status | Granada | Spain | Unknown status |
| Department of Neonatology, Hospital Universitario La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Universitari Sant Joan de Reus Coordinator of this site? Confirm its status | Reus | Spain | Unknown status |
| Hospital Universitari Joan XXIII de Tarragona Coordinator of this site? Confirm its status | Tarragona | Spain | Unknown status |
| INCLIVA Health Research Institute Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
| Hospital Clinico Universitario Lozano Blesa, Instituto de investigacion Sanitaria de Aragon Coordinator of this site? Confirm its status | Zaragoza | Spain | Unknown status |
| Wojewodzki Specjalistyczny Szpital Dzieciecy Coordinator of this site? Confirm its status | Olsztyn | Poland | Unknown status |
| Karol Jonscher's University Hospital Coordinator of this site? Confirm its status | Poznan | Poland | Unknown status |
| Medical College of Rzeszow University Coordinator of this site? Confirm its status | Rzeszów | Poland | Unknown status |
| Children's Memorial Health Institute Coordinator of this site? Confirm its status | Warsaw | Poland | Unknown status |
Related publications
- Whole goat milk versus cow milk formula and atopic dermatitis in infants: A randomized clinical trial.Clin Nutr · 2026 · PMID 42275985
This page is information, not medical advice. Discuss any trial with your doctor.