Study protocol for the safety and efficacy of probiotic therapy on days alive and out of hospital in adult ICU patients: the multicentre, randomised, placebo-controlled Restoration Of gut microflora in Critical Illness Trial (ROCIT).

Anne-Marie Palermo, Fiona M Wood, Brad Wibrow, Sharon Waterson, Tobias Strunk, Sam Salman, Bernhard Richter, Adrian Regli, Anu Rammohan, Edward Raby, Susan Pellicano, Andrew Paparini, Edward Litton, Katrina Orr, Erina Myers, Laurens Manning, Jolene Lim, Alisa Higgins, Joel Gummer, Janet Ferrier, Andrew Currie, Andy R Chapman, David Broadhurst, Matthew Anstey

Journal: BMJ open 2021;10(6):e035930

PMID: 32565465

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Abstract

INTRODUCTION

The effect of early and sustained administration of daily probiotic therapy on patients admitted to the intensive care unit (ICU) remains uncertain.

METHODS AND ANALYSIS

The Restoration Of gut microflora in Critical Illness Trial (ROCIT) study is a multicentre, randomised, placebo-controlled, parallel-group, two-sided superiority trial that will enrol 220 patients in five ICUs. Adult patients who are within 48 hours of admission to an ICU and are expected to require intensive care beyond the next calendar day will be randomised in a 1:1 ratio to receive early and sustained 299v probiotic therapy in addition to usual care or placebo in addition to usual care. The primary endpoint is days alive and out of hospital to day 60.

ETHICS AND DISSEMINATION

ROCIT has been approved by the South Metropolitan Health Service Human Research Ethics Committee (ref: RGS00000004) and the St John of God Health Care Human Research Ethics Committee (ref: 1183). The trial results will be submitted for publication in a peer-reviewed journal.

TRIAL REGISTRATION NUMBER

Australian and New Zealand Clinical Trials Registry (ANZCTR12617000783325); Pre-results.

Address: Intensive Care Unit, Fiona Stanley Hospital, Murdoch, Western Australia, Australia [email protected].; Intensive Care Unit, St John of God Hospital, Subiaco, Western Australia, Australia.; Intensive Care Unit, Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia.; School of Science, Edith Cowan University, Joondalup, Western Australia, Australia.; Intensive Care Unit, Royal Perth Hospital, Perth, Western Australia, Australia.; Murdoch University, Murdoch, Western Australia, Australia.; Australian and New Zealand Intensive Care Research Centre, Monash University, Clayton, Victoria, Australia.; Intensive Care Unit, Fiona Stanley Hospital, Murdoch, Western Australia, Australia.; University of Western Australia, Perth, Western Australia, Australia.; Pharmacy, Fiona Stanley Hospital, Murdoch, Western Australia, Australia.; Department of Infectious Diseases, Fiona Stanley Hospital, Murdoch, Western Australia, Australia.; Department of Economics, University of Western Australia, Crawley, Western Australia, Australia.; Intensive Care Unit, St John of God Hospital, Murdoch, Western Australia, Australia.; Division of Cardiology, Medical University of Vienna, Wien, Wien, Austria.; Neonatal Directorate, King Edward Memorial Hospital for Women Perth, Subiaco, Western Australia, Australia.; Burns Department, Fiona Stanley Hospital, Murdoch, Western Australia, Australia.

DOI: 10.1136/bmjopen-2019-035930

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MeSH Terms: Australia, Critical Care, Critical Illness, Equivalence Trials as Topic, Gastrointestinal Microbiome, Humans, Intensive Care Units, Multicenter Studies as Topic, New Zealand, Probiotics, Research Design