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Downloaded from Protocol summary for the randomised, placebo-controlled restoration of gut microflora in critical illness trial (ROCIT) Journal: BMJ Open ManuscriptFor ID peerbmjopen-2019-035930 review only Article Type: Protocol Date Submitted by the 25-Nov-2019 Author: Complete List of Authors: Litton, Edward; University of Western Australia, Anstey, Matthew; Sir Charles Gairdner Hospital, ICU Broadhurst, David; Edith Cowan University Chapman, Andy; Royal Perth Hospital Currie, Andrew; Murdoch University Ferrier, Janet; St John of God Health Care, ICU Gummer, Joel; Murdoch University Higgins, Alisa; Monash University Lim, Jolene; Fiona Stanley Hospital Manning, Laurens; University of Western Australia Myer, Erina; Sir Charles Gairdner Hospital, ICU Orr, Katrina; Fiona Stanley Hospital Palermo, Anne-Marie; Fiona Stanley Hospital paparini, andrew; Murdoch University http://bmjopen.bmj.com/ Pellicano, Susan; Fiona Stanley Hospital, ICU Raby, Ed; Fiona Stanley Hospital, Infectious Diseases Rammohan, Anu; University of Western Australia, Economics Regli, Adrian; St John of God Health Care Richter, Bernhard; Medical University of Vienna, Division of Cardiology Salman, Sam; University of Western Australia Strunk, Tobias; King Edward Memorial Hospital for Women Perth, Neonatal Directorate Waterson, Sharon; Royal Perth Hospital, ICU Wibrow, Brad; Sir Charles Gairdner Hospital, ICU on October 1, 2021 by guest. Protected copyright. Wood, Fiona; Fiona Stanley Hospital; University of Western Australia Adult intensive & critical care < ANAESTHETICS, Diagnostic microbiology Keywords: < INFECTIOUS DISEASES, Adult intensive & critical care < INTENSIVE & CRITICAL CARE For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 1 of 25 BMJ Open 1 2 3 4 5 BMJ Open: first published as 10.1136/bmjopen-2019-035930 on 21 June 2020. 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Protected copyright. 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 2 of 25 1 2 3 Protocol summary for the randomised, placebo-controlled restoration of gut microflora in 4 5 critical illness trial (ROCIT) BMJ Open: first published as 10.1136/bmjopen-2019-035930 on 21 June 2020. Downloaded from 6 7 Edward Litton, Consultant, ICU, Fiona Stanley Hospital, Perth, Western Australia, Research 8 Fellow School of Medicine, University of Western Australia, Perth, Western Australia, 9 [email protected] 10 11 Matt Anstey Consultant, ICU, Sir Charles Gairdner Hospital, Perth, Western Australia, Clinical 12 Senior Lecturer, University of Western Australia, Perth, Western Australia 13 [email protected] 14 David Broadhurst, Professor, School of Science, Edith Cowan University, Joondalup 15 16 [email protected] 17 Andy Chapman, Consultant ICU, Royal Perth Hospital, Perth, Western Australia 18 [email protected] peer review only 19 Andrew Currie, Senior Lecturer, Medical, Molecular & Forensic Sciences, Murdoch 20 21 University, Perth, Western Australia [email protected] 22 Janet Ferrier, Research Coordinator, Intensive Care Unit, St John of God Hospital Subiaco 23 Perth, Western Australia [email protected] 24 Joel Gummer, Research Fellow, Health Futures Institute, Murdoch University, Perth, 25 26 Western Australia, [email protected] 27 Alisa Higgins, Research Fellow, Australian and New Zealand Intensive Care Research Centre, 28 Monash University, Melbourne, Australia [email protected] 29 Jolene Lim, Registrar, ICU, Fiona Stanley Hospital, Perth, Western Australia, 30 31 [email protected] 32 Laurens Manning, Infectious Diseases Physician, Fiona Stanley Hospital 33 University of Western Australia, [email protected] 34 Erina Myers, Research coordinator, Intensive Care Unit, Sir Charles Gairdner Hospital, Perth, 35 WA, [email protected] 36 Katrina Orr, Supervisor Pharmacist Investigational Drugs, Fiona Stanley Hospital, Murdoch, 37 http://bmjopen.bmj.com/ 38 WA 6150, [email protected] 39 Anna Palermo, Research Manager, ICU, Fiona Stanley Hospital, Perth, Western Australia 40 [email protected] 41 42 Andrew Paparini, Adjunct Senior Research Fellow, Murdoch University; Director, Chief 43 Scientist, Econumerics Pty Ltd Consultants, Perth WA, [email protected] 44 Susan Pellicano, Research Manager and ROCIT study manager, ICU, Fiona Stanley Hospital, 45 Perth, WA [email protected] on October 1, 2021 by guest. Protected copyright. 46 Ed Raby, Consultant, Infectious Diseases, Fiona Stanley Hospital, Perth, Western Australia, 47 48 [email protected] 49 Anu Rammohan, Professor, Department of Economics, University of Western Australia, 50 [email protected] 51 Adrian Regli, Consultant, ICU, St John of God Hospital, Murdoch, WA 6150 52 Clinical Associate Professor, University of Western Australia, [email protected] 53 54 Bernhard Richter, Consultant, Division of Cardiology, Medical University of Vienna, 55 Waehringer Guertel 18-20, Vienna, Austria [email protected] 56 Sam Salman, Clinical Senior Lecturer, Medical School, University of Western Australia, 57 Crawley, WA, 6009, [email protected] 58 59 Tobias Strunk, Consultant Neonatologist, Neonatal Directorate, King Edward Memorial 60 Hospital; Telethon Kids Institute, Perth, WA [email protected] For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 3 of 25 BMJ Open 1 2 3 4 5 Sharon Waterson, Research coordinator, Royal Perth Hospital, Perth, WA BMJ Open: first published as 10.1136/bmjopen-2019-035930 on 21 June 2020. Downloaded from 6 [email protected] 7 Brad Wibrow, Intensivist, Sir Charles Gairdner Hospital, Perth, WA 8 [email protected] 9 Fiona Wood, Director of the Burns Service FSH and Burn Injury Research unit UWA 10 11 [email protected] 12 13 Corresponding Author: 14 15 16 Edward Litton FCICM, Intensive Care Unit, Fiona Stanley Hospital, Perth, WA 17 18 [email protected] peer review only 19 20 [email protected] 21 22 23 Tel: +61415 293 281 24 25 Word Count: 2072 26 27 Key Words: Gut microbiome, critical illness, probiotics 28 29 30 31 32 33 34 35 36 37 http://bmjopen.bmj.com/ 38 39 40 Abstract 41 42 Introduction 43 44 The effect of early and sustained administration of daily probiotic therapy on patients 45 on October 1, 2021 by guest. Protected copyright. 46 47 admitted to the intensive care unit (ICU) remains uncertain. 48 49 Methods and analysis 50 51 52 The restoration of gut microflora in critical illness trial (ROCIT) study is a multicentre, 53 54 randomised, placebo-controlled, parallel-group, two-sided superiority trial that will enrol 55 56 57 220 patients in five ICUs.