000125975 001__ 125975 000125975 005__ 20230516110857.0 000125975 0247_ $$2doi$$a10.1136/bmjopen-2022-070533 000125975 0248_ $$2sideral$$a133525 000125975 037__ $$aART-2023-133525 000125975 041__ $$aeng 000125975 100__ $$aFerry, Jill Marie 000125975 245__ $$aEffects 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 000125975 260__ $$c2023 000125975 5060_ $$aAccess copy available to the general public$$fUnrestricted 000125975 5203_ $$aAtopic 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. 000125975 540__ $$9info:eu-repo/semantics/openAccess$$aby-nc$$uhttp://creativecommons.org/licenses/by-nc/3.0/es/ 000125975 655_4 $$ainfo:eu-repo/semantics/article$$vinfo:eu-repo/semantics/publishedVersion 000125975 700__ $$aGalera-Martínez, Rafael 000125975 700__ $$aCampoy, Cristina 000125975 700__ $$aSáenz de Pipaón, Miguel 000125975 700__ $$aJarocka-Cyrta, Elzbieta 000125975 700__ $$aWalkowiak, Jaroslaw 000125975 700__ $$aRomanczuk, Bartosz 000125975 700__ $$aEscribano, Joaquin 000125975 700__ $$aGispert, Mariona 000125975 700__ $$aGrattarola, Paula 000125975 700__ $$aGruszfeld, Dariusz 000125975 700__ $$0(orcid)0000-0002-2219-3646$$aIglesia, Iris 000125975 700__ $$aGrote, Veit 000125975 700__ $$aDemmelmair, Hans 000125975 700__ $$aHandel, Uschi 000125975 700__ $$aGallier, Sophie 000125975 700__ $$aKoletzko, Berthold 000125975 773__ $$g13, 4 (2023), e070533 [8 pp.]$$pBMJ Open$$tBMJ Open$$x2044-6055 000125975 8564_ $$s556734$$uhttps://zaguan.unizar.es/record/125975/files/texto_completo.pdf$$yVersión publicada 000125975 8564_ $$s3215475$$uhttps://zaguan.unizar.es/record/125975/files/texto_completo.jpg?subformat=icon$$xicon$$yVersión publicada 000125975 909CO $$ooai:zaguan.unizar.es:125975$$particulos$$pdriver 000125975 951__ $$a2023-05-16-09:11:02 000125975 980__ $$aARTICLE