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
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 statist...
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2023-04-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/13/4/e070533.full |
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| author | 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 |
| author_facet | 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 |
| author_sort | Berthold Koletzko |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-09T18:00:00Z |
| format | Article |
| id | doaj.art-5e6d135491f44e839f08684cdd5f8b22 |
| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2024-04-09T18:00:00Z |
| publishDate | 2023-04-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj.art-5e6d135491f44e839f08684cdd5f8b222023-04-14T07:30:07ZengBMJ Publishing GroupBMJ Open2044-60552023-04-0113410.1136/bmjopen-2022-070533Effects 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) trialBerthold Koletzko0Jarosław Walkowiak1Veit Grote2Hans Demmelmair3Cristina Campoy4Joaquin Escribano5Mariona Gispert6Jill Marie Ferry7Rafael Galera-Martínez8Miguel Sáenz de Pipaón9Elzbieta Jarocka-Cyrta10Bartosz Romańczuk11Paula Grattarola12Dariusz Gruszfeld13Iris Iglesia14Uschi Handel15Sophie Gallier16Division of Metabolic and Nutritional Medicine, Department of Paediatrics, Dr von Hauner Children′s Hospital, University Hospital, Ludwig Maximilian University Munich, Munich, Germany1 Department of Pediatric Gastroenterology and Metabolic Diseases, Poznan University of Medical Sciences, Poznan, PolandDivision of Metabolic and Nutritional Medicine, Department of Paediatrics, Dr von Hauner Children′s Hospital, University Hospital, Ludwig Maximilian University Munich, Munich, Germany3Division of Metabolic and Nutritional Medicine, Ludwig-Maximilians-Universität München, Dr von Hauner Children`s Hospital, University of Munich Medical Centre, Munich, Germany12 Department of Paediatrics, University of Granada, Granada, SpainDept. Paediatrics, Universitat Rovira i Virgili, Tarragona, SpainDept. Paediatrics, Universitat Rovira i Virgili, Tarragona, SpainDivision of Metabolic and Nutritional Medicine, Department of Paediatrics, Dr von Hauner Children′s Hospital, University Hospital, Ludwig Maximilian University Munich, Munich, GermanyUnit of Pediatric Gastroenterology and Nutrition, Torrecárdenas University Hospital, Almería, SpainDepartment of Neonatology, Hospital Universitario La Paz, Madrid, SpainDepartment of Pediatrics, Gastroenterology, and Nutrition, Regional Specialized Children’s Hospital in Olsztyn, Medical Faculty Collegium Medicum University of Warmia and Mazury, Olsztyn, PolandDepartment of Pediatrics, Medical College, University of Rzeszów, Rzeszów, PolandINCLIVA Biomedical Research Institute, Valencia, SpainDepartment of Paediatric, Children’s Memorial Health Institute in Warsaw, Warsaw, PolandAgrifood Institute of Aragon (IA2), Growth, Exercise, Nutrition and Development (GENUD) Research Group, University of Zaragoza, Zaragoza, SpainDivision of Metabolic and Nutritional Medicine, Department of Paediatrics, Dr von Hauner Children′s Hospital, University Hospital, Ludwig Maximilian University Munich, Munich, GermanyDairy Goat Co-operative (NZ), Hamilton, New ZealandIntroduction 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.https://bmjopen.bmj.com/content/13/4/e070533.full |
| spellingShingle | 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 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 |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| url | https://bmjopen.bmj.com/content/13/4/e070533.full |
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