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Active, not recruiting Not applicable

Goat Infant Formula Feeding and Eczema (the GIraFFE Study)

NCT04599946 · tracked via the Priya Life Science Poland tracker
Sponsor
Dairy Goat Co-operative (N.Z.) Limited
Phase
Not applicable
Started
2021-01-08
Last updated
2026-08-27

Condition(s) studied

Dermatitis, AtopicEczema, InfantileInfant DevelopmentChild Development

Investigational drug(s) / intervention(s)

Infant formula and follow-on formula made from whole goat milkInfant formula and follow-on formula made from cow's milk ingredients

Infant formula and follow-on formula made from whole goat milk: Infant formula and follow-on formula made from whole goat milk

Infant formula and follow-on formula made from cow's milk ingredients: Infant formula and follow-on formula made from cow's milk ingredients

Study summary

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.

Eligibility

Sex
ALL
Min age
0 Days
Max age
90 Days
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • Cumulative incidence of atopic dermatitis up to the age of 12 months — Age 12 months
    Cumulative incidence of atopic dermatitis up to the age of 12 months diagnosed by study personnel (defined as meeting the UK Working Party Diagnostic Criteria for atopic dermatitis)

Trial sites (12)

FacilityCityRegionStatus
Dr. von Hauner Children's Hospital, LMU University Hospital Munich Munich Germany
Wojewodzki Specjalistyczny Szpital Dzieciecy Olsztyn Poland
Karol Jonscher's University Hospital Poznan Poland
Medical College of Rzeszow University Rzeszów Poland
Children's Memorial Health Institute Warsaw Poland
Unit of Pediatric Gastroenterology and Nutrition, Torrecardenas University Hospital Almería Spain
EURISTIKOS Excellence Centre for Paediatric Research, University of Granada Granada Spain
Department of Neonatology, Hospital Universitario La Paz Madrid Spain
Hospital Universitari Sant Joan de Reus Reus Spain
Hospital Universitari Joan XXIII de Tarragona Tarragona Spain
INCLIVA Health Research Institute Valencia Spain
Hospital Clinico Universitario Lozano Blesa, Instituto de investigacion Sanitaria de Aragon Zaragoza Spain
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04599946 on ClinicalTrials.gov ↗ ← All trials in Poland