Article Text

Protocol
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
  1. Jill Marie Ferry1,
  2. Rafael Galera-Martínez2,
  3. Cristina Campoy3,4,
  4. Miguel Sáenz de Pipaón5,
  5. Elzbieta Jarocka-Cyrta6,
  6. Jarosław Walkowiak7,
  7. Bartosz Romańczuk8,
  8. Joaquin Escribano9,10,
  9. Mariona Gispert9,
  10. Paula Grattarola11,
  11. Dariusz Gruszfeld12,
  12. Iris Iglesia13,14,
  13. Veit Grote1,
  14. Hans Demmelmair1,
  15. Uschi Handel1,
  16. Sophie Gallier15,
  17. Berthold Koletzko1
  1. 1Division of Metabolic and Nutritional Medicine, Department of Paediatrics, Dr von Hauner Children′s Hospital, University Hospital, Ludwig Maximilian University Munich, Munich, Germany
  2. 2Unit of Pediatric Gastroenterology and Nutrition, Torrecárdenas University Hospital, Almería, Spain
  3. 3Department of Paediatrics, EURISTIKOS Excellence Centre for Paediatric Research, School of Medicine, University of Granada, Granada, Spain
  4. 4Instituto Biosanitario de Granada (Ibs-Granada), Fundación Parque Tecnológico de Ciencias de la Salud de Granada, Granada, Spain
  5. 5Department of Neonatology, Hospital Universitario La Paz, Madrid, Spain
  6. 6Department of Pediatrics, Gastroenterology, and Nutrition, Regional Specialized Children’s Hospital in Olsztyn, Medical Faculty Collegium Medicum University of Warmia and Mazury, Olsztyn, Poland
  7. 7Department of Pediatric Gastroenterology and Metabolic Diseases, Poznan University of Medical Sciences, Poznan, Poland
  8. 8Department of Pediatrics, Medical College, University of Rzeszów, Rzeszów, Poland
  9. 9IISPV, Pediatric Nutrition and Human Development Research Unit, Universitat Rovira i Virgili, Tarragona, Spain
  10. 10Department of Paediatric, Hospital Universitari Sant Joan de Reus, Reus, Spain
  11. 11INCLIVA Biomedical Research Institute, Valencia, Spain
  12. 12Department of Paediatric, Children’s Memorial Health Institute in Warsaw, Warsaw, Poland
  13. 13Agrifood Institute of Aragon (IA2), Growth, Exercise, Nutrition and Development (GENUD) Research Group, University of Zaragoza, Zaragoza, Spain
  14. 14Instituto de Investigación Sanitaria Aragón (IIS-Aragón), Zaragoza, Spain
  15. 15Dairy Goat Co-operative (NZ), Hamilton, New Zealand
  1. Correspondence to Professor Berthold Koletzko; office.koletzko{at}med.uni-muenchen.de

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.

  • Eczema
  • NUTRITION & DIETETICS
  • Paediatric dermatology
  • IMMUNOLOGY
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Footnotes

  • Contributors The conception and design of the study were developed by BK, VG, HD, UH and SG. JMF produced the first draft of the manuscript and all coauthors RG-M, CC, MSdP, EJ-C, JW, BR, JE, MG, PG, DG, II, VG, HD, UH, SG and BK critically reviewed the manuscript and approved the final version. RG-M, CC, MSdP, EJ-C, JW, BR, JE, MG, PG, DG and II participated in the set-up of the study.

  • Funding 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.

  • Disclaimer The sponsor, the site principal investigators and the key principal investigator have agreed and fixed in the study protocol that the final decision-making power on the study rests with the trial steering committee, which includes the key principal investigator, all site principal investigators and the sponsor. The trial steering committee also takes decisions on further grant applications to fund additional analyses of data and biosamples generated in GIraFFE.

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

  • Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.