Goat Infant Formula Feeding and Eczema:
Atopic dermatitis (eczema) affects all ages but is especially concerning in infants. An Australian study found possible differences in eczema rates during the first year between infants fed whole goat’s milk formula and those fed cow’s milk formula. Both formulas support the growth and nutrition of infants, but they differ in fat and protein composition1-2.
The GIraFFE Study aims to explore whether these differences influence the development of eczema or allergies, which could help improve formula composition and nutrition guidelines.
Objective
The GIraFFE study aims to compare whether whole goat milk formula and standard cow milk infant formula have different effects on the development of atopic dermatitis and other related allergic diseases, by analysing a large infant cohort. The infant formulas used in the GIraFFE study comply with European regulations and are manufactured in New Zealand using milk collected from grass-fed goats and cows in this area. Both formulas are safe, well-tolerated, and ensure normal growth and development in infants.
About the GIraFFE study
The study is led by Professor Berthold Koletzko and his research team from the University of Munich, in close cooperation with the principal investigators from ten collaborating Research Centers in Poland and Spain. The GIraFFE Study is being conducted in accordance with the guidelines of the International Council for Harmonisation – Good Clinical Practice. The health and well-being of the children in the study are paramount.
To protect breastfeeding, the GIraFFE study only contacted those parents who intended or were already feeding their babies with infant formula. If parents agreed to participate, they visited a study centre with their child, and the child was randomly assigned to receive either standard cow milk formula or whole goat milk formula until the age of 12 months.
The study formulas were made in the New Zealand factory and are available commercially. The safety and tolerability of whole goat milk formula were demonstrated in two clinical studies1-2. A positive opinion from the European Food Safety Authority (EFSA, 2012) confirmed that goat milk formula is safe and nutritionally adequate for infants, provided it meets the EU’s regulations. It supports normal growth and development.
Over 2,100 children are part of the GIraFFE Study. All the children reached the age of 12 months in August 2024 and 24 months in August 2025. At the end of 2025, the first five-year-olds will have completed the study. The parents have told us their experience in the study is very positive. Many would like their new children to be involved; unfortunately, the enrolment period has ended.
Many parents are as curious about what type of study formula their child has received as are the researchers. However, to prevent any potential influence on study results, parents and study staff cannot know which formula a child has received until all the data is collected.
There are many interesting aspects of the study, and we will add updates as the results are published. It has been possible to include measures that provide information about other aspects of allergies and child development, which will give new insights for doctors.
We’re deeply grateful to the infants and parents currently involved in this study. Their ongoing commitment is helping shape better health outcomes for future generations.
The study has been registered in clinicaltrials.gov as NCT04599946.
Updates
In October 2024, Professor B. Koletzko presented the learnings from the study team’s experience with implementing a large multicentre formula feeding study at the European Academy of Paediatric Societies (EAPS 2024, Vienna). Participation in the study has been strong, with the number of children continuing in the study being high. This is due to our loyal study parents and children, and their important contribution – thank you!
In April 2023, the GIraFFE Study design was published to allow scientists and experts to understand what the study is about3.
Collaborative teams of the GIraFFE Study
Research Management Team in Germany:
Prof Berthold Koletzko, Dr von Hauner Children’s Hospital, LMU University Hospital, Munich.
Collaborating Research Centres 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
Collaborating Research Centres 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:
The GIraFFE StudyTM is co-funded by Dairy Goat Co-operative and the New Zealand Ministry for Primary Industries as part of the Caprine Innovations NZ Programme under the Sustainable Food & Fibre Futures partnership.
Data protection: The Ethics Committees of the Research and Management team and of all the collaborating centers have reviewed and approved the procedures to protect the personal data of the participants in the GIraFFE Study, as well as the correct compliance with the General Data Protection Regulation (GDPR). Study participants will receive detailed information on data protection individually.
References:
- 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.
- 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.
- Ferry, et al. (2023). «Effects of infant feeding with goat milk formula or cow milk formula on atopic dermatitis: protocol of the randomised controlled Goat Infant Formula Feeding and Eczema (GIraFFE) trial.» BMJ open, 13(4), e070533.
