Article Text
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.
- adult intensive & critical care
- diagnostic microbiology
- adult intensive & critical care
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Footnotes
Twitter @ed_litton
Correction notice This article has been corrected since it was published. Name for the Andrea Paparini has been corrected.
Contributors EL has made a substantial contribution to the design of the work and drafting the work and has given final approval for the work and agrees to be accountable for all aspects of the work. MA, DB, ACh, ACu, JF, JG, AH, JL, LM, EM, KO, A-MP, AP, SP, ER, ARa, ARe, BR, SS, TS, SW, BW, FW has made a substantial contribution to the design of the work and revising the work and has given final approval for the work and agrees to be accountable for all aspects of the work.
Funding ROCIT is funded by grants from the Department of Health, Government of Western Australia Research Translation Projects, the St John of God Hospital Foundation and the Fiona Wood Foundation. Study drug was supplied by Health World. The funding bodies and Health World had no input into the design or conduct of the trial and will have no input into the analysis or reporting of the trial results. The study sponsor is the Fiona Stanley Fremantle Hospital Group, South Metropolitan Health Service, Western Australia.
Competing interests None declared.
Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.
Patient consent for publication Not required.
Provenance and peer review Not commissioned; externally peer reviewed.