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)

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

doi:10.1136/bmjopen-2019-035930

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)

BMJ Open. 2020 Jun 21;10(6):e035930. doi: 10.1136/bmjopen-2019-035930.

Authors

Edward Litton^{1

2}, Matthew Anstey³, David Broadhurst⁴, Andy R Chapman⁵, Andrew Currie⁶, Janet Ferrier², Joel Gummer⁶, Alisa Higgins⁷, Jolene Lim⁸, Laurens Manning⁹, Erina Myers³, Katrina Orr¹⁰, Anne-Marie Palermo⁸, Andrew Paparini⁶, Susan Pellicano⁸, Edward Raby¹¹, Anu Rammohan¹², Adrian Regli^{8

13}, Bernhard Richter^{8

14}, Sam Salman⁹, Tobias Strunk¹⁵, Sharon Waterson⁵, Brad Wibrow³, Fiona M Wood^{9

16}

Affiliations

¹ Intensive Care Unit, Fiona Stanley Hospital, Murdoch, Western Australia, Australia [email protected].
² Intensive Care Unit, St John of God Hospital, Subiaco, Western Australia, Australia.
³ Intensive Care Unit, Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia.
⁴ School of Science, Edith Cowan University, Joondalup, Western Australia, Australia.
⁵ Intensive Care Unit, Royal Perth Hospital, Perth, Western Australia, Australia.
⁶ Murdoch University, Murdoch, Western Australia, Australia.
⁷ Australian and New Zealand Intensive Care Research Centre, Monash University, Clayton, Victoria, Australia.
⁸ Intensive Care Unit, Fiona Stanley Hospital, Murdoch, Western Australia, Australia.
⁹ University of Western Australia, Perth, Western Australia, Australia.
¹⁰ Pharmacy, Fiona Stanley Hospital, Murdoch, Western Australia, Australia.
¹¹ Department of Infectious Diseases, Fiona Stanley Hospital, Murdoch, Western Australia, Australia.
¹² Department of Economics, University of Western Australia, Crawley, Western Australia, Australia.
¹³ Intensive Care Unit, St John of God Hospital, Murdoch, Western Australia, Australia.
¹⁴ Division of Cardiology, Medical University of Vienna, Wien, Wien, Austria.
¹⁵ Neonatal Directorate, King Edward Memorial Hospital for Women Perth, Subiaco, Western Australia, Australia.
¹⁶ Burns Department, Fiona Stanley Hospital, Murdoch, Western Australia, Australia.

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 Lactobacillus plantarum 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.

Keywords: adult intensive & critical care; diagnostic microbiology.

Publication types

Clinical Trial Protocol
Research Support, Non-U.S. Gov't

MeSH terms

Australia
Critical Care / methods*
Critical Illness*
Equivalence Trials as Topic*
Gastrointestinal Microbiome*
Humans
Intensive Care Units
Multicenter Studies as Topic
New Zealand
Probiotics / therapeutic use*
Research Design