Atopic dermatitis (eczema) affects all age groups but can be a particular concern for infants and small children. In a small study in Australia1, a difference was found in the number of infants developing atopic dermatitis in first year of life fed goat milk formulas compared to cow milk formulas.
While goat milk and cow milk formulas provide very similar growth and nutritional outcomes in infants2 if breastfeeding is not possible, they slightly differ in their composition, types of fat and proteins.
We want to test if it is these differences that play a role in the development of atopic dermatitis or allergies. Understanding the role of these factors in the development of atopic dermatitis and allergies will help to improve formula composition and guidelines for infant nutrition.
Aim
The aim of the GIraFFE study is to compare if goat milk and cow milk formulas have different effects on the development of atopic dermatitis and other related allergic diseases in a larger number of infants (n = 2296).
The study has been registered at clinicaltrials.gov as NCT04599946.
What is involved?
To protect breastfeeding, only parents who intend to or are already feeding their infant formula will be approached. If parents agree to participate, their child will be randomly assigned to receive a goat or a cow milk formula up to the age of 12 months. Participation in the GIraFFE study begins during the first 3 months of life. Further visits are planned at the age of 4, 6, 12, 24 and 60 months of age. The visits will include examination of the child for signs of atopic dermatitis, anthropometric measurements, questionnaires on allergy, health, diet and general behavior, and voluntary collection of biological samples.
Who can participate?
Healthy term born infants less than 3 months old without cow milk allergy or intolerance to cow milk and without a doctor’s diagnosis of atopic dermatitis.
Research team
The study is led by Prof B. Koletzko and his research team at the University of Munich, in co-operation with the principal investigators at the co-investigator sites in Poland and Spain.
What about the quality of the formulas?
Both formulas comply with European regulations and are manufactured in New Zealand using New Zealand milk collected from pasture-fed goats and cows. Both formulas have been shown to be safe, well tolerated and support normal growth and development of infants.
Who to contact if you want more information, have a question or want to participate?
For more information, you can contact your nearest research teams by filling the form below. We will contact you as soon as possible.
Collaborative teams of the GIraFFE Study
Research Management Team in Germany:
Prof Berthold Koletzko, Dr von Hauner Children’s Hospital, University of Munich Medical Center.
Co-investigator Sites in Poland:
- Olsztyn: Prof Elzbieta Jarocka-Cyrta, Children’s Hospital
- Poznań: Prof Jaroslaw Walkowiak, Karol Jonscher Clinical Hospital, Poznań University of Medical Sciences
- Rzeszów: Prof Artur Mazur, University of Rzeszów
- Warsaw: Prof Dariusz Gruszfeld and Prof Janusz Książyk, Children’s Memorial Health Institute
Co-investigator sites in Spain:
- Almeria: Dr Rafael Galera, Torrecárdenas University Hospital
- Granada: Prof Cristina Campoy, EURISTIKOS Excellence Centre for Paediatric Research
- Madrid: Prof Miguel Sáenz de Pipaón, Hospital Universitario La Paz
- Tarragona and Reus: Prof Ricardo Closa Monasterolo and Prof Joaquin Escribano Subías, Hospital Universitari Joan XXIII and Hospital Universitari Sant Joan, IISPV/URV
- Valencia: Prof Cecilia Martínez Costa, Hospital Clínico Universitario de Valencia, INCLIVA Health Research Institute
- Zaragoza: Prof Gerardo Rodríguez, Zaragoza University
Funding:
Dairy Goat Co-operative and the New Zealand Ministry for Primary Industries are co-funding the GIraFFE study as part of the Caprine Innovations NZ (CAPRINZ) programme under the Sustainable Food & Fibre Futures partnership.
Data protection: The procedures to protect the personal data of the study participants and compliance to the General Data Protection Regulation (GDPR) have been reviewed and approved by the ethics committees of the research management team and the co-investigator sites. Study participants will receive detailed information on data protection separately.
References: 1 Zhou, et al. (2014). “Nutritional adequacy of goat milk infant formulas for term infants: a double-blind randomised controlled trial.” British Journal of Nutrition 111: 1641-1651.
2 Grant, C., et al. (2005). “Randomized, double‐blind comparison of growth in infants receiving goat milk formula versus cow milk infant formula.” Journal of Paediatrics and Child Health 41(11): 564-568.
