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Arch Dis Child Fetal Neonatal Ed

Title:		Mechanisms affecting the gut of preterm infants in enteral feeding trials: a nested cohort within a randomised controlled trial of lactoferrin
Author(s):		Young G; Berrington JE; Cummings S; Dorling J; Ewer AK; Frau A; Lett L; Probert C; Juszczak E; Kirby J; Beck LC; Renwick VL; Lamb C; Lanyon CV; McGuire W; Stewart C; Embleton N;
Address:		"Applied Sciences, Northumbria University Faculty of Health and Life Sciences, Newcastle upon Tyne, England, UK. Microbial Environments, Hub for Biotechnology in the Built Environment, Newcastle upon Tyne, England, UK. Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, UK j.e.berrington@newcastle.ac.uk. Newcastle Neonatal Service, Ward 35 Neonatal Unit, Royal Victoria Infirmary, Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle Upon Tyne, UK. School of Health and Life Sciences, Teesside University, Middlesbrough, North Yorkshire, UK. Department of Neonatal Medicine, University Hospital Southampton NHS Foundation Trust, Southampton, UK. Institute of Metabolism and Systems Research, University of Birmingham, Birmingham, UK. Gastroenterology Research Unit, Institute of Translational Medicine, University of Liverpool, Liverpool, UK. School of Medicine, University of Nottingham School of Medicine, Nottingham, Notts, UK. Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, UK. Centre for Reviews and Dissemination, University of York, York, North Yorkshire, UK. Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK"
Journal Title:		Arch Dis Child Fetal Neonatal Ed
Year:		2023
Volume:		20221117
Issue:		3
Page Number:		272 - 279
DOI:		10.1136/archdischild-2022-324477
ISSN/ISBN:		1468-2052 (Electronic) 1359-2998 (Print) 1359-2998 (Linking)
Abstract:		"OBJECTIVE: To determine the impact of supplemental bovine lactoferrin on the gut microbiome and metabolome of preterm infants. DESIGN: Cohort study nested within a randomised controlled trial (RCT). Infants across different trial arms were matched on several clinical variables. Bacteria and metabolite compositions of longitudinal stool and urine samples were analysed to investigate the impact of lactoferrin supplementation. SETTING: Thirteen UK hospitals participating in a RCT of lactoferrin. PATIENTS: 479 infants born <32 weeks' gestation between June 2016 and September 2017. RESULTS: 10 990 stool and 22 341 urine samples were collected. Analyses of gut microbiome (1304 stools, 201 infants), metabolites (171 stools, 83 infants; 225 urines, 90 infants) and volatile organic compounds (314 stools, 117 infants) were performed. Gut microbiome Shannon diversity at 34 weeks corrected age was not significantly different between infants in the lactoferrin (mean=1.24) or placebo (mean=1.06) groups (p=0.11). Lactoferrin receipt explained less than 1% variance in microbiome compositions between groups. Metabolomic analysis identified six discriminative features between trial groups. Hospital site (16%) and postnatal age (6%) explained the greatest variation in microbiome composition. CONCLUSIONS: This multiomic study identified minimal impacts of lactoferrin but much larger impacts of hospital site and postnatal age. This may be due to the specific lactoferrin product used, but more likely supports the findings of the RCT in which this study was nested, which showed no impact of lactoferrin on reducing rates of sepsis. Multisite mechanistic studies nested within RCTs are feasible and help inform trial interpretation and future trial design"
Keywords:		"Infant, Newborn Infant Humans *Lactoferrin Enteral Nutrition Infant, Premature *Sepsis Gestational Age Intensive Care Units, Neonatal Microbiology Molecular Biology Neonatology Sepsis;"
Notes:		"MedlineYoung, Greg Berrington, Janet E Cummings, Stephen Dorling, Jon Ewer, Andrew K Frau, Alessandra Lett, Lauren Probert, Chris Juszczak, Ed Kirby, John Beck, Lauren C Renwick, Victoria L Lamb, Christopher Lanyon, Clare V McGuire, William Stewart, Christopher Embleton, Nicholas eng Randomized Controlled Trial England 2022/11/18 Arch Dis Child Fetal Neonatal Ed. 2023 May; 108(3):272-279. doi: 10.1136/archdischild-2022-324477. Epub 2022 Nov 17"