Format

Send to

Choose Destination
Trials. 2016 Aug 2;17:377. doi: 10.1186/s13063-016-1495-x.

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

Author information

1
Department of Medicine, McMaster University, McMaster Health Sciences Center, Room 2C11, 1200 Main Street W, Hamilton, ON, Canada. debcook@mcmaster.ca.
2
Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, ON, Canada. debcook@mcmaster.ca.
3
Public Health Ontario, Toronto, ON, Canada.
4
St. Joseph's Health Center, Toronto, ON, Canada.
5
Department of Medicine, University of Toronto, Toronto, ON, Canada.
6
Department of Surgery, University of Toronto, Toronto, ON, Canada.
7
Interdepartmental Division of Critical Care, University of Toronto, Toronto, ON, Canada.
8
Research Center of the CHU de Québec - Population Health and Optimal Health Practices Research Unit, Université Laval, Quebec City, QC, Canada.
9
Department of Medicine, Université Laval, Quebec City, QC, Canada.
10
Department of Anesthesiology and Critical Care, Université Laval, Quebec City, QC, Canada.
11
Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, ON, Canada.
12
Division of Critical Care Medicine, St. Paul's Hospital and University of British Columbia, Vancouver, BC, Canada.
13
Center for Health Evaluation and Outcome Sciences, St. Paul's Hospital and University of British Columbia, Vancouver, BC, Canada.
14
Division of Critical Care, University of Ottawa, Ottawa, ON, Canada.
15
Division of Critical Care Medicine, Vancouver General Hospital, Vancouver, BC, Canada.
16
Department of Critical Care Medicine, Mercy Hospital, St Louis, MO, USA.
17
Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN, USA.
18
Department of Anesthesia & Critical Care, Vancouver Island Health Authority, Victoria, BC, Canada.
19
Department of Medicine, McMaster University, McMaster Health Sciences Center, Room 2C11, 1200 Main Street W, Hamilton, ON, Canada.
20
Department of Pathology and Molecular Medicine, McMaster University, Hamilton, ON, Canada.
21
Biochemistry and Biomedical Sciences Department, McMaster University, Hamilton, ON, Canada.
22
King Saud Bin Abdulaziz University for Health Sciences and King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.

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 × 10(10) 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.

KEYWORDS:

Critically ill; Infection; Intensive care; Probiotics

PMID:
27480757
PMCID:
PMC4970233
DOI:
10.1186/s13063-016-1495-x
[Indexed for MEDLINE]
Free PMC Article

Supplemental Content

Full text links

Icon for BioMed Central Icon for PubMed Central
Loading ...
Support Center