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1. 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)

Author

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

Subjects
Medicine
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.

Published
2020
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2. 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)

Author

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

Subjects
medicine.medical_specialty, Critical Care, Critical Illness, lcsh:Medicine, Equivalence Trials as Topic, Placebo, law.invention, Superiority Trial, law, Intensive care, Health care, medicine, Clinical endpoint, Humans, Multicenter Studies as Topic, adult intensive & critical care, Protocol (science), business.industry, Probiotics, lcsh:R, Australia, Intensive Care, General Medicine, diagnostic microbiology, Intensive care unit, Gastrointestinal Microbiome, Clinical trial, Intensive Care Units, Research Design, Emergency medicine, business, New Zealand
Abstract

IntroductionThe effect of early and sustained administration of daily probiotic therapy on patients admitted to the intensive care unit (ICU) remains uncertain.Methods and analysisThe 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 disseminationROCIT 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 numberAustralian and New Zealand Clinical Trials Registry (ANZCTR12617000783325); Pre-results.

Published
2020

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