GIraFFE Study Overview
The GIraFFE (Goat Infant Formula Feeding and Eczema) Study is one of the largest clinical trials designed to investigate whether Whole Goat Milk Formula (WGF) could prevent atopic dermatitis (AD) in infancy, compared with standard cow milk formula (CF). This page outlines the background, design, and scientific context of the study.
The GIraFFE Study™: Whole Goat Milk versus Cow Milk Formula and Atopic Dermatitis in Infants
The Goat Infant Formula Feeding and Eczema (GIraFFE) Study is one of the largest clinical trials designed to investigate whether Whole Goat Milk Formula (WGF), compared with standard cow milk formula (CF), could prevent atopic dermatitis (AD) in infants up to 12 months of age
Conducted across 10 university research centres in Spain and Poland, the study enrolled 2,132 healthy, term infants and used a multicentre, randomised, double-blind, controlled design.
The study was developed to provide robust clinical evidence on the relationship between infant formula composition and the development of atopic dermatitis during the first year of life.
Why was the GIraFFE Study™ needed?
Understanding atopic dermatitis (eczema)
Atopic dermatitis (AD), more commonly known as eczema, is a chronic inflammatory skin condition characterised by dry, itchy and inflamed skin. It commonly begins during infancy and typically follows a pattern of flares and periods of remission.
Eczema affects approximately 15-30% of children worldwide,1 although prevalence and severity vary between countries.2
There are various gene changes that affect the skin barrier and immune response, increasing the likelihood of eczema. Environmental factors, such as allergens and other irritants, can trigger and exacerbate symptoms, leading to flare-ups.
Family history is the most significant known risk factor. Having one parent with atopic dermatitis may increase a child’s risk by approximately two to three times.3
Atopic dermatitis develops through a complex interaction between genetic, immune and environmental factors
Genetic factors, such as filaggrin gene mutations.
Impaired skin barrier function due to infection or environmental factors.
A family history of eczema or allergic disease
The wider impact of eczema
Eczema is more than a skin rash. Persistent itching, discomfort and recurring flares can have a considerable impact on children and their families.
Possible consequences include:
- Broken skin and an increased risk of infection
- Disturbed sleep
- Reduced quality of life
- Psychological and emotional impact
- Difficulties with concentration and cognitive performance
- Missed nursery, school and social activities
- Increased healthcare and treatment costs
Eczema is not just a childhood disease – Approximately 10% of children continue to experience eczema into adulthood.
Children with atopic dermatitis are also at increased risk of developing food allergy, asthma and hay fever5, a progression often referred to as the allergic march.
- The risk of food allergies is 6 times higher in children with atopic dermatitis.
- The risk of asthma and hay fever is more than 1.5 times higher.
Why prevention matters
Preventing atopic dermatitis before it develops has the potential to reduce the burden of disease for children and families, while also helping to reduce the risk of progression to other allergic conditions later in childhood.
Several approaches have been investigated for their potential to reduce the risk of eczema in infants:
- Exclusively breastfeeding for at least 4 to 6 months has a protective effect of breastfeeding in the general population of infants and provides even greater protection for infants with a family history of eczema, reducing risk by approximately 40%.6
- Hydrolysed formulas may reduce the risk of eczema in infants with a family history by up to 25%.7, 8
- Supporting the skin barrier, including the early use of emollients (such as those containing ceramides) and water softeners, may also provide benefits for infants at high risk of eczema.6
Why investigate Whole Goat Milk Formula (WGF)?
Despite advances in understanding eczema prevention, relatively little clinical research has explored whether the composition of standard infant formula itself may influence the development of atopic dermatitis.4
Whole Goat Milk Formula (WGF) differs from conventional whey-adjusted cow milk formula in both its protein and fat composition. Earlier clinical observations, together with pre-clinical research, suggested that these natural differences may influence eczema development.4
A post hoc analysis of the TIGGA study observed a trend towards approximately one-third lower cumulative incidence of eczema during the first 12 months in infants fed Whole Goat Milk Formula (WGF) compared with standard cow milk formula. Although the study was not powered to investigate eczema as a primary outcome, these findings provided the scientific rationale for conducting the GIraFFE Study, a large, multicentre randomised controlled trial specifically designed to investigate this question.9
What is Whole Goat Milk Formula (WGF)?
Whole Goat Milk Formula (WGF) refers to infant formula in which whole goat milk provides the sole milk protein source, with approximately 50% of the total fat provided by natural goat milk fat, rather than relying on isolated milk proteins (skim milk and added whey) or vegetable oils.
Its defining features include:
- Whole goat milk as the sole milk protein source
- Natural 20:80 whey:casein ratio
- Approximately 50% of fat from goat milk
- No added whey
Together with earlier clinical observations and pre-clinical research, these compositional characteristics provided the scientific rationale for the GIraFFE Study.
Study Objectives
Main objective: To assess the effect of infant feeding with whole goat milk or cow milk infant formula on atopic dermatitis development during the first year of life.
Secondary objectives:
- Child growth
- Sleep
- Gastrointestinal symptoms
- Nutrition
- Quality of life
- Blood and stool health markers
Participants are being measured until 5 years of age.
Study Design
The GIraFFE Study™ is a multicenter, randomised, double-blind, controlled nutritional trial (Study Protocol).
Infants were recruited before the age of 3 months and randomly assigned to receive whole goat milk formula or cow milk formula. Only healthy full-term infants whose parents had chosen to initiate formula feeding for reasons unrelated to the trial. There were no selection criteria related to the risk of atopic dermatitis. Caregivers and their child completed assessments at either in-person visits or phone calls every two months, up to the age of 12 months, and periodically thereafter.
The study was undertaken by trained study personnel and principal investigators at each study site. Growth measures and adverse events were conducted in accordance with Good Clinical Practice. Precautions were taken to ensure that the recruitment process did not interfere with breastfeeding intention or practices.
For the primary outcome measure for atopic dermatitis, the required sample size of 1,722 infants was calculated based on an atopic dermatitis incidence of 15% and a 30% risk reduction. A dropout of up to 25% was initially assumed, leading to a planned enrollment of 2,296 infants. However, recruitment was stopped after reaching a total of 2,132 infants, as the observed dropout rate was lower than initially assumed.
Intervention
Participants were randomly assigned to receive either:
- Whole goat milk formula with 20:80 whey:casein ratio and ~50% milk fat as total fat
- Standard cow milk formula with 60:40 whey:casein ratio and vegetable oil as the predominant source of fat (milk fat 5% of total fat)
How was atopic dermatitis assessed?
For the outcomes related to eczema, the participants were assessed for atopic dermatitis by several methods:
- ADPrimary: Trained study personnel assessed infants at 4, 6 and 12 months using the validated UK Working Party (UKWP) diagnostic criteria.
- ADUKWP: Additional UKWP assessments were completed during telephone follow-up at 8 and 10 months, allowing further eczema cases to be identified between clinic visits.
- ADDoctor: Parents also reported any diagnosis of atopic dermatitis made by a healthcare professional throughout the study period, reflecting routine clinical practice.
- ADAny: A combined outcome incorporating all infants diagnosed using either assessment method.
Adapted from Ferry, et al. 20234
Collaborative International Research
- The GIraFFE Study is led by the Comprehensive Childhood Research Center, Ludwig-Maximilians-Universität, Munich.
- The Study involves 10 university research centres across Poland and Spain, with experience in clinical trials and led by Principal Investigators with expertise in infant and childhood nutrition.
- This work is supported by Dairy Goat Co-operative (NZ) Limited and the New Zealand Ministry for Primary Industries as part of the Caprine Innovations NZ Sustainable Food & Fibre Futures Partnership Programme (grant number PGP06- 16001).
Explore the clinical findings
The GIraFFE Study generated one of the largest clinical datasets investigating Whole Goat Milk Formula (WGF) and atopic dermatitis.
References
- Bieber N. N Engl J Med 2008;358:1483-1494
- Silverberg et al. Asthma & Immunology 2021; 126(4):417-428
- Ravn et al. J Allergy Clin Immunol 2020;145:1182-93
- Ferry et al. BMJ Open 2023; 13(4):e070533
- Tsuge et al. Children 2021;8(11):1067
- Chu et al. J Allerg Clin Immun 2024;12(7):1695-1704
- Li et al. Advances in Nutrition 2024;15(5):100217
- Vandenplas et al. Journal of Pediatric Gastroenterology and Nutrition 2024;78.2:386-413
- Zhou et al. Br J Nutr. 2014; 111(9):1641–1651.
GIraFEE Study Publications
Grote et al., 2025
Whole goat milk formula (WGF) versus cow milk formula, and atopic dermatitis (AD) in infants: A randomised clinical trial
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
Carpenter et al., 2017
Prevalence and cumulative incidence of eczema in infants fed goat or cow milk based formula
