Probiotics to Prevent Severe Pneumonia and Endotracheal Colonization Trial

Summary

Probiotics are commercially available live bacteria thought to have health benefits when ingested. A literature review of probiotic studies in the intensive care unit (ICU) found that in patients who receive probiotics, there is a 25% reduction in lung infection, known as ventilator-associated pneumonia (VAP). There is also an 18% reduction in the chance of developing any infection in the ICU. However, the studies reviewed were small and not well done. Therefore, whether probiotics are really helpful or not is unclear. Before a large carefully performed study is done to evaluate the effects of probiotics in critically ill patients, a pilot trial was needed. The Investigators completed a multicenter pilot RCT for which the primary outcomes relate to feasibility. Feasibility goals were met. 1) Recruitment for the Pilot was achieved in 1 year; 2) Adherence to the protocol was 96%; 3) There were no cases of contamination; 4) The VAP rate was 15%. This study is very important in the ongoing search for more effective strategies to prevent serious infection during critical illness. Probiotics may be an easy-to-use, readily available, inexpensive approach to help future critically ill patients around the world.

Timeline

Start

2015-06

Primary completion

2019-03-13

Completion

2020-11-17

Publications

• Fernando SM, Muscedere J, Rochwerg B, Johnstone J, Daneman N, Marshall JC, Lauzier F, Rudkowski JC, Arabi YM, Heels-Ansdell D, Sligl W, Kristof AS, Duan E, Dionne JC, St-Arnaud C, Reynolds S, Khwaja K, Cook DJ; PROSPECT Investigators and the Canadian Critical Care Trials Group. Frailty and the risk of ICU-acquired infections in a randomised trial: a protocol and statistical analysis plan. BMJ Open. 2025 Nov 13;15(11):e105227. doi: 10.1136/bmjopen-2025-105227.
• Thabane A, Heels-Ansdell D, Zytaruk N, Johnstone J, Lauzier F, Arabi YM, Muscedere J, Clarke F, Hand L, Watpool I, Porteous R, Sandu G, Santos M, Tassy D, Marshall J, McIntyre L, Ball I, Rochwerg B, Karachi T, Zarychanski R, Marquis F, Friedrich JO, Lysecki P, Cook D; PROSPECT Investigators and the Canadian Critical Care Trials Group. Coenrollment of critically ill patients in PROSPECT: characteristics and association with treatment efficacy and safety. Trials. 2025 Sep 26;26(1):370. doi: 10.1186/s13063-025-09028-w.
• Takaoka A, Johnstone J, Lauzier F, Heels-Ansdell D, Davis M, Zytaruk N, Duan E, Dionne J, Saunders L, Arabi YM, Marshall J, Thabane L, Clarke F, Hand L, Masse MH, Rochwerg B, McIntyre L, Girard M, Freitag A, Karachi T, Cook DJ; PROSPECT Investigators; Canadian Critical Care Trials Group. Enrolment patterns in a randomized controlled trial of probiotics in critically ill patients: a retrospective analysis of the PROSPECT trial. Trials. 2024 Dec 27;25(1):851. doi: 10.1186/s13063-024-08701-w.
• Dionne JC, Johnstone J, Heels-Ansdell D, Duan E, Lauzier F, Arabi YM, Adhikari NKJ, Sligl W, Dodek P, Rochwerg B, Marshall JC, Niven DJ, Williamson DR, Reynolds S, Zytaruk N, Cook D. Clostridioides difficile infection in mechanically ventilated critically ill patients: A nested cohort study. J Crit Care. 2023 Jun;75:154254. doi: 10.1016/j.jcrc.2023.154254. Epub 2023 Jan 20.
• Takaoka A, Zytaruk N, Davis M, Matte A, Johnstone J, Lauzier F, Marshall J, Adhikari N, Clarke FJ, Rochwerg B, Lamontagne F, Hand L, Watpool I, Porteous RK, Masse MH, D'Aragon F, Niven D, Heels-Ansdell D, Duan E, Dionne J, English S, St-Arnaud C, Millen T, Cook DJ; PROSPECT Investigators and the Canadian Critical Care Trials Group. Monitoring and auditing protocol adherence, data integrity and ethical conduct of a randomized clinical trial: A case study. J Crit Care. 2022 Oct;71:154094. doi: 10.1016/j.jcrc.2022.154094. Epub 2022 Jun 17.
• Johnstone J, Meade M, Lauzier F, Marshall J, Duan E, Dionne J, Arabi YM, Heels-Ansdell D, Thabane L, Lamarche D, Surette M, Zytaruk N, Mehta S, Dodek P, McIntyre L, English S, Rochwerg B, Karachi T, Henderson W, Wood G, Ovakim D, Herridge M, Granton J, Wilcox ME, Goffi A, Stelfox HT, Niven D, Muscedere J, Lamontagne F, D'Aragon F, St-Arnaud C, Ball I, Nagpal D, Girard M, Aslanian P, Charbonney E, Williamson D, Sligl W, Friedrich J, Adhikari NK, Marquis F, Archambault P, Khwaja K, Kristof A, Kutsogiannis J, Zarychanski R, Paunovic B, Reeve B, Lellouche F, Hosek P, Tsang J, Binnie A, Trop S, Loubani O, Hall R, Cirone R, Reynolds S, Lysecki P, Golan E, Cartin-Ceba R, Taylor R, Cook D; Prevention of Severe Pneumonia and Endotracheal Colonization Trial (PROSPECT) Investigators and the Canadian Critical Care Trials Group. Effect of Probiotics on Incident Ventilator-Associated Pneumonia in Critically Ill Patients: A Randomized Clinical Trial. JAMA. 2021 Sep 21;326(11):1024-1033. doi: 10.1001/jama.2021.13355.
• Johnstone J, Heels-Ansdell D, Thabane L, Meade M, Marshall J, Lauzier F, Duan EH, Zytaruk N, Lamarche D, Surette M, Cook DJ; PROSPECT Investigators and the Canadian Critical Care Trials Group. Evaluating probiotics for the prevention of ventilator-associated pneumonia: a randomised placebo-controlled multicentre trial protocol and statistical analysis plan for PROSPECT. BMJ Open. 2019 Jun 20;9(6):e025228. doi: 10.1136/bmjopen-2018-025228.

Drugs

Indications