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Published in: Trials 1/2016

Open Access 01-12-2016 | Research

Probiotics: Prevention of Severe Pneumonia and Endotracheal Colonization Trial—PROSPECT: a pilot trial

Authors: Deborah J. Cook, Jennie Johnstone, John C. Marshall, Francois Lauzier, Lehana Thabane, Sangeeta Mehta, Peter M. Dodek, Lauralyn McIntyre, Joe Pagliarello, William Henderson, Robert W. Taylor, Rodrigo Cartin-Ceba, Eyal Golan, Margaret Herridge, Gordon Wood, Daniel Ovakim, Tim Karachi, Michael G. Surette, Dawn M. E. Bowdish, Daphnee Lamarche, Chris P. Verschoor, Erick H. Duan, Diane Heels-Ansdell, Yaseen Arabi, Maureen Meade, For the PROSPECT Investigators and the Canadian Critical Care Trials Group

Published in: Trials | Issue 1/2016

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Abstract

Background

Probiotics are live microorganisms that may confer health benefits when ingested. Randomized trials suggest that probiotics significantly decrease the incidence of ventilator-associated pneumonia (VAP) and the overall incidence of infection in critically ill patients. However, these studies are small, largely single-center, and at risk of bias. The aim of the PROSPECT pilot trial was to determine the feasibility of conducting a larger trial of probiotics to prevent VAP in mechanically ventilated patients in the intensive care unit (ICU).

Methods

In a randomized blinded trial, patients expected to be mechanically ventilated for ≥72 hours were allocated to receive either 1 × 1010 colony-forming units of Lactobacillus rhamnosus GG or placebo, twice daily. Patients were excluded if they were at increased risk of L. rhamnosus GG infection or had contraindications to enteral medication. Feasibility objectives were: (1) timely recruitment; (2) maximal protocol adherence; (3) minimal contamination; and (4) estimated VAP rate ≥10 %. We also measured other infections, diarrhea, ICU and hospital length of stay, and mortality.

Results

Overall, in 14 centers in Canada and the USA, all feasibility goals were met: (1) 150 patients were randomized in 1 year; (2) protocol adherence was 97 %; (3) no patients received open-label probiotics; and (4) the VAP rate was 19 %. Other infections included: bloodstream infection (19.3 %), urinary tract infections (12.7 %), and skin and soft tissue infections (4.0 %). Diarrhea, defined as Bristol type 6 or 7 stools, occurred in 133 (88.7 %) of patients, the median length of stay in ICU was 12 days (quartile 1 to quartile 3, 7–18 days), and in hospital was 26 days (quartile 1 to quartile 3, 14–44 days); 23 patients (15.3 %) died in the ICU.

Conclusions

The PROSPECT pilot trial supports the feasibility of a larger trial to investigate the effect of L. rhamnosus GG on VAP and other nosocomial infections in critically ill patients.

Trial registration

Clinicaltrials.gov NCT01782755. Registered on 29 January 2013.
Appendix
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Metadata
Title
Probiotics: Prevention of Severe Pneumonia and Endotracheal Colonization Trial—PROSPECT: a pilot trial
Authors
Deborah J. Cook
Jennie Johnstone
John C. Marshall
Francois Lauzier
Lehana Thabane
Sangeeta Mehta
Peter M. Dodek
Lauralyn McIntyre
Joe Pagliarello
William Henderson
Robert W. Taylor
Rodrigo Cartin-Ceba
Eyal Golan
Margaret Herridge
Gordon Wood
Daniel Ovakim
Tim Karachi
Michael G. Surette
Dawn M. E. Bowdish
Daphnee Lamarche
Chris P. Verschoor
Erick H. Duan
Diane Heels-Ansdell
Yaseen Arabi
Maureen Meade
For the PROSPECT Investigators and the Canadian Critical Care Trials Group
Publication date
01-12-2016
Publisher
BioMed Central
Published in
Trials / Issue 1/2016
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-016-1495-x

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