Evidence map›Paper›PMID 27480757›Full record

Trial reportTrials2016

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

Deborah J Cook, Jennie Johnstone, John C Marshall, Francois Lauzier, Lehana Thabane, Sangeeta Mehta, Peter M Dodek, Lauralyn McIntyre, Joe Pagliarello, William Henderson and 16 more

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01782755 (Probiotics), which is not on this map. Cited by 22 papers.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed
4.7field-weighted citation impact, top 5% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01782755 phase2completednot on this map

Probiotics: Prevention of Severe Pneumonia and Endotracheal Colonization Trial (PROSPECT): A Feasibility Clinical Trial

TypeinterventionalSponsorMcMaster UniversityRan2013 to 2015Enrolled150ConditionsVentilator Associated Pneumonia (VAP), Other Infections, Antibiotic-Associated Diarrhea, C-DifficileArmsL. rhamnosus GG - Probiotic, Placebo - Microcrystalline Cellulose
3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 54 citations in OpenAlex.

  1. Trial
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  17. Probiotics in Medicine: A Long Debate.Frontiers in immunology · 2020
    Review
  18. Review
  19. Article
  20. Observational
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

26 authors at 10 institutions in 3 countries.

Deborah J CookDepartment of Medicine, McMaster University, McMaster Health Sciences Center, Room 2C11, 1200 Main Street W, Hamilton, ON, Canada. debcook@mcmaster.ca.
Jennie JohnstonePublic Health Ontario, Toronto, ON, Canada.
John C MarshallDepartment of Surgery, University of Toronto, Toronto, ON, Canada.
Francois LauzierResearch Center of the CHU de Québec - Population Health and Optimal Health Practices Research Unit, Université Laval, Quebec City, QC, Canada.
Lehana ThabaneDepartment of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, ON, Canada.
Sangeeta MehtaDepartment of Medicine, University of Toronto, Toronto, ON, Canada.
Peter M DodekDivision of Critical Care Medicine, St. Paul's Hospital and University of British Columbia, Vancouver, BC, Canada.
Lauralyn McIntyreDivision of Critical Care, University of Ottawa, Ottawa, ON, Canada.
Joe PagliarelloDivision of Critical Care, University of Ottawa, Ottawa, ON, Canada.
William HendersonDivision of Critical Care Medicine, Vancouver General Hospital, Vancouver, BC, Canada.
Robert W TaylorDepartment of Critical Care Medicine, Mercy Hospital, St Louis, MO, USA.
Rodrigo Cartin-CebaDivision of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN, USA.
Eyal GolanDepartment of Medicine, University of Toronto, Toronto, ON, Canada.
Margaret HerridgeDepartment of Medicine, University of Toronto, Toronto, ON, Canada.
Gordon WoodDepartment of Anesthesia & Critical Care, Vancouver Island Health Authority, Victoria, BC, Canada.
Daniel OvakimDepartment of Anesthesia & Critical Care, Vancouver Island Health Authority, Victoria, BC, Canada.
Tim KarachiDepartment of Medicine, McMaster University, McMaster Health Sciences Center, Room 2C11, 1200 Main Street W, Hamilton, ON, Canada.
Michael G SuretteDepartment of Medicine, McMaster University, McMaster Health Sciences Center, Room 2C11, 1200 Main Street W, Hamilton, ON, Canada.
Dawn M E BowdishDepartment of Pathology and Molecular Medicine, McMaster University, Hamilton, ON, Canada.
Daphnee LamarcheBiochemistry and Biomedical Sciences Department, McMaster University, Hamilton, ON, Canada.
Chris P VerschoorDepartment of Pathology and Molecular Medicine, McMaster University, Hamilton, ON, Canada.
Erick H DuanDepartment of Medicine, McMaster University, McMaster Health Sciences Center, Room 2C11, 1200 Main Street W, Hamilton, ON, Canada.
Diane Heels-AnsdellDepartment of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, ON, Canada.
Yaseen ArabiKing Saud Bin Abdulaziz University for Health Sciences and King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.
Maureen MeadeDepartment of Medicine, McMaster University, McMaster Health Sciences Center, Room 2C11, 1200 Main Street W, Hamilton, ON, Canada.
PROSPECT Investigators and the Canadian Critical Care Trials Group
McMaster University · CAUniversity of Toronto · CAIsland Health · CAKing Saud bin Abdulaziz University for Health Sciences · SAUniversity of British Columbia · CAUniversity of Ottawa · CAMayo Clinic · USMayo Clinic in Florida · USThe Quebec Population Health Research Network · CAVancouver General Hospital · CA

Funding

CIHR
6 · The paper itself

Abstract

backgroundProbiotics 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).

methodsIn 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.

resultsOverall, 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.

conclusionsThe 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 registrationClinicaltrials.gov NCT01782755 . Registered on 29 January 2013.

Indexed as

AdultAgedCanadaFeasibility StudiesFemaleHospital MortalityHumansIntensive Care UnitsIntubation, IntratrachealLacticaseibacillus rhamnosusLength of StayMaleMiddle AgedPilot ProjectsPneumonia, BacterialPneumonia, Ventilator-AssociatedCritically illInfectionIntensive careProbiotics

Identifiers

PMID27480757
PMCPMC4970233
OpenAlexW2499848072

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.