TY - JOUR
T1 - Probiotics
T2 - Prevention of Severe Pneumonia and Endotracheal Colonization Trial-PROSPECT: A pilot trial
AU - the PROSPECT Investigators and the Canadian Critical Care Trials Group
AU - Cook, Deborah J.
AU - Johnstone, Jennie
AU - Marshall, John C.
AU - Lauzier, Francois
AU - Thabane, Lehana
AU - Mehta, Sangeeta
AU - Dodek, Peter M.
AU - McIntyre, Lauralyn
AU - Pagliarello, Joe
AU - Henderson, William
AU - Taylor, Robert W.
AU - Cartin-Ceba, Rodrigo
AU - Golan, Eyal
AU - Herridge, Margaret
AU - Wood, Gordon
AU - Ovakim, Daniel
AU - Karachi, Tim
AU - Surette, Michael G.
AU - Bowdish, Dawn M.E.
AU - Lamarche, Daphnee
AU - Verschoor, Chris P.
AU - Duan, Erick H.
AU - Heels-Ansdell, Diane
AU - Arabi, Yaseen
AU - Meade, Maureen
N1 - Funding Information:
This investigator-initiated trial was peer-review funded by the Canadian Institute of Health Research, Technology Evaluation for the Elderly, Physicians’ Services Incorporated, and the Hamilton Academy of Health Sciences Research Organization. The probiotic and placebo were donated by iHealth, the distributers of Culturelle’s L. rhamnosus GG product. None of these groups played a role in the design, conduct, analysis, interpretation, or reporting of this protocol. DJC holds a Chair of the Canadian Institutes of Health Research. JJ held a Canadian Institute of Health Research Fellowship award while preparing the protocol. FL is a recipient of a Research Career Award from the Fonds de la recherche du Québec-Santé. MGS holds a Canada Research Chair in Interdisciplinary Microbiome Research. DMEB holds a Canada Research Chair in Aging and Immunity.
Publisher Copyright:
© 2016 Cook et al.
PY - 2016/8/2
Y1 - 2016/8/2
N2 - 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.
AB - 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.
KW - Critically ill
KW - Infection
KW - Intensive care
KW - Probiotics
UR - http://www.scopus.com/inward/record.url?scp=84979783729&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84979783729&partnerID=8YFLogxK
U2 - 10.1186/s13063-016-1495-x
DO - 10.1186/s13063-016-1495-x
M3 - Article
C2 - 27480757
AN - SCOPUS:84979783729
SN - 1745-6215
VL - 17
JO - Trials
JF - Trials
IS - 1
M1 - 377
ER -