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
Berthold Koletzko,
Jarosław Walkowiak,
Veit Grote,
Hans Demmelmair,
Cristina Campoy,
Joaquin Escribano,
Mariona Gispert,
Jill Marie Ferry,
Rafael Galera-Martínez,
Miguel Sáenz de Pipaón,
Elzbieta Jarocka-Cyrta,
Bartosz Romańczuk,
Paula Grattarola,
Dariusz Gruszfeld,
Iris Iglesia,
Uschi Handel,
Sophie Gallier
Affiliations
Berthold Koletzko
1 International Paediatric Association, Geneva, Switzerland
Jarosław Walkowiak
1 Department of Pediatric Gastroenterology and Metabolic Diseases, Poznan University of Medical Sciences, Poznan, Poland
Veit Grote
Department of Pediatrics, Munich University Hospital Dr von Hauner Children`s Hospital, Munchen, Germany
Hans Demmelmair
Division of Metabolic and Nutritional Medicine, Department of Paediatrics, Dr von Hauner Children′s Hospital, University Hospital, Ludwig Maximilian University Munich, Munich, Germany
Cristina Campoy
Department of Paediatrics, EURISTIKOS Excellence Centre for Paediatric Research, School of Medicine, University of Granada, Granada, Spain
Joaquin Escribano
IISPV, Pediatric Nutrition and Human Development Research Unit, Universitat Rovira i Virgili, Tarragona, Spain
Mariona Gispert
IISPV, Pediatric Nutrition and Human Development Research Unit, Universitat Rovira i Virgili, Tarragona, Spain
Jill Marie Ferry
Division of Metabolic and Nutritional Medicine, Department of Paediatrics, Dr von Hauner Children′s Hospital, University Hospital, Ludwig Maximilian University Munich, Munich, Germany
Rafael Galera-Martínez
Unit of Pediatric Gastroenterology and Nutrition, Torrecárdenas University Hospital, Almería, Spain
Miguel Sáenz de Pipaón
Department of Neonatology, Hospital Universitario La Paz, Madrid, Spain
Elzbieta Jarocka-Cyrta
Department of Pediatrics, Gastroenterology, and Nutrition, Regional Specialized Children’s Hospital in Olsztyn, Medical Faculty Collegium Medicum University of Warmia and Mazury, Olsztyn, Poland
Bartosz Romańczuk
Department of Pediatrics, Medical College, University of Rzeszów, Rzeszów, Poland
Paula Grattarola
INCLIVA Biomedical Research Institute, Valencia, Spain
Dariusz Gruszfeld
Department of Paediatric, Children’s Memorial Health Institute in Warsaw, Warsaw, Poland
Iris Iglesia
Agrifood Institute of Aragon (IA2), Growth, Exercise, Nutrition and Development (GENUD) Research Group, University of Zaragoza, Zaragoza, Spain
Uschi Handel
Division of Metabolic and Nutritional Medicine, Department of Paediatrics, Dr von Hauner Children′s Hospital, University Hospital, Ludwig Maximilian University Munich, Munich, Germany
Sophie Gallier
Fonterra Research and Development Centre, Palmerston North, New Zealand
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.
