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 Ferry, Jill Marie Campoy Folgoso, Cristina The study products are manufactured and provided to participants by the study sponsor (Dairy Goat Co-operative (NZ), Hamilton, New Zealand). The sponsor has allocated a fixed budget to each of the institutions hosting the study centre and the key principal investigator with his team to conduct the study. This work was 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). BK is the Else Kröner Seniorprofessor of Paediatrics at LMU – University of Munich, financially supported by the charitable Else Kröner-Fresenius-Foundation, LMU Medical Faculty and LMU University Hospitals. Introduction Atopic dermatitis (AD) is a chronic, inflammatory skin condition significantly affecting quality of life. A small randomised trial showed an approximately one-third lower incidence of AD in goat milk formula-fed compared with cow milk formula-fed infants. However, due to limited statistical power, AD incidence difference was not found to be significant. This study aims to explore a potential risk reduction of AD by feeding a formula based on whole goat milk (as a source of protein and fat) compared with a formula based on cow milk proteins and vegetable oils. Methods and analysis This two-arm (1:1 allocation), parallel, randomised, double-blind, controlled nutritional trial shall enrol up to 2296 healthy term-born infants until 3 months of age, if parents choose to start formula feeding. Ten study centres in Spain and Poland are participating. Randomised infants receive investigational infant and follow-on formulas either based on whole goat milk or on cow milk until the age of 12 months. The goat milk formula has a whey:casein ratio of 20:80 and about 50% of the lipids are milk fat from whole goat milk, whereas the cow milk formula, used as control, has a whey:casein ratio of 60:40 and 100% of the lipids are from vegetable oils. The energy and nutrient levels in both goat and cow milk formulas are the same. The primary endpoint is the cumulative incidence of AD until the age of 12 months diagnosed by study personnel based on the UK Working Party Diagnostic Criteria. The secondary endpoints include reported AD diagnosis, measures of AD, blood and stool markers, child growth, sleep, nutrition and quality of life. Participating children are followed until the age of 5 years. Ethics and dissemination Ethical approval was obtained from the ethical committees of all participating institutions. Trial registration number NCT04599946. 2023-07-27T08:15:14Z 2023-07-27T08:15:14Z 2023-04 journal article Ferry JM, Galera-Martínez R, Campoy C, et al. 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 2023;13:e070533. [doi: 10.1136/bmjopen-2022-070533] https://hdl.handle.net/10481/84038 10.1136/bmjopen-2022-070533 eng http://creativecommons.org/licenses/by-nc/4.0/ open access Atribución-NoComercial 4.0 Internacional BMJ