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. 2023 Apr 13;13(4):e070533.
doi: 10.1136/bmjopen-2022-070533.

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

Jill Marie Ferry  1 , Rafael Galera-Martínez  2 , Cristina Campoy  3   4 , Miguel Sáenz de Pipaón  5 , Elzbieta Jarocka-Cyrta  6 , Jarosław Walkowiak  7 , Bartosz Romańczuk  8 , Joaquin Escribano  9   10 , Mariona Gispert  9 , Paula Grattarola  11 , Dariusz Gruszfeld  12 , Iris Iglesia  13   14 , Veit Grote  1 , Hans Demmelmair  1 , Uschi Handel  1 , Sophie Gallier  15 , Berthold Koletzko  16
Affiliations

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

Jill Marie Ferry et al. BMJ Open. .

Abstract

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.

Keywords: Eczema; IMMUNOLOGY; NUTRITION & DIETETICS; Paediatric dermatology.

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Conflict of interest statement

Competing interests: SG is an employee of DGC (Dairy Goat Co-operative (NZ), Hamilton, New Zealand).

Figures

Figure 1
Figure 1
Schematic representation of the study design.
See this image and copyright information in PMC

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