Abstract

Study design

Randomised double-blind factorial-design placebo-controlled trial.

Objective

Urinary tract infections (UTIs) are common in people with spinal cord injury (SCI). UTIs are increasingly difficult to treat due to emergence of multi-resistant organisms. Probiotics are efficacious in preventing UTIs in post-menopausal women. We aimed to determine whether probiotic therapy with Lactobacillus reuteri RC-14+Lactobacillus GR-1 (RC14-GR1) and/or Lactobacillus rhamnosus GG+Bifidobacterium BB-12 (LGG-BB12) are effective in preventing UTI in people with SCI.

Setting

Spinal units in New South Wales, Australia with their rural affiliations.

Methods

We recruited 207 eligible participants with SCI and stable neurogenic bladder management. They were randomised to one of four arms: RC14-GR1+LGG-BB12, RC14-GR1+placebo, LGG-BB12+ placebo or double placebos for 6 months. Randomisation was stratified by bladder management type and inpatient or outpatient status. The primary outcome was time to occurrence of symptomatic UTI.

Results

Analysis was based on intention to treat. Participants randomised to RC14-GR1 had a similar risk of UTI as those not on RC14-GR1 (HR 0.67; 95% CI: 0.39–1.18; P = 0.17) after allowing for pre-specified covariates. Participants randomised to LGG-BB12 also had a similar risk of UTI as those not on LGG-BB12 (HR 1.29; 95% CI: 0.74–2.25; P = 0.37). Multivariable post hoc survival analysis for RC14-GR1 only vs. the other three groups showed a potential protective effect (HR 0.46; 95% CI: 0.21–0.99; P = 0.03), but this result would need to be confirmed before clinical application.

Conclusion

In this RCT, there was no effect of RC14-GR1 or LGG-BB12 in preventing UTI in people with SCI.

Details

Title
Probiotics [LGG-BB12 or RC14-GR1] versus placebo as prophylaxis for urinary tract infection in persons with spinal cord injury [ProSCIUTTU]: a randomised controlled trial
Author
Swee-Ling, Toh 1 ; Lee Bonsan Bonne 2 ; Ryan, Suzanne 3 ; Simpson, Judy M 4 ; Clezy Kate 5 ; Bossa Laetitia 6 ; Rice, Scott Alan 7   VIAFID ORCID Logo  ; Obaydullah, Marial 3 ; Weber, Gerard Hogan 8 ; Kaur Jasbeer 9 ; Boswell-Ruys, Claire Louise 2 ; Goodall, Stephen 10 ; Middleton, James Walter 11 ; Tuderhope, Mark 9 ; Kotsiou, George 9 

1  Prince of Wales Hospital, Department of Spinal and Rehabilitation Medicine, Sydney, Australia (GRID:grid.415193.b); University of Sydney, School of Public Health, Sydney, Australia (GRID:grid.1013.3) (ISNI:0000 0004 1936 834X) 
2  Prince of Wales Hospital, Department of Spinal and Rehabilitation Medicine, Sydney, Australia (GRID:grid.415193.b); Neuroscience Research Australia [NeuRA] and the University of New South Wales, Sydney, Australia (GRID:grid.1005.4) (ISNI:0000 0004 4902 0432) 
3  Neuroscience Research Australia [NeuRA] and the University of New South Wales, Sydney, Australia (GRID:grid.1005.4) (ISNI:0000 0004 4902 0432) 
4  University of Sydney, School of Public Health, Sydney, Australia (GRID:grid.1013.3) (ISNI:0000 0004 1936 834X) 
5  Prince of Wales Hospital, Department of Infectious Diseases, Sydney, Australia (GRID:grid.415193.b) 
6  Neuroscience Research Australia [NeuRA] and the University of New South Wales, Sydney, Australia (GRID:grid.1005.4) (ISNI:0000 0004 4902 0432); University of New South Wales, Centre for Marine Bio-Innovation, Sydney, Australia (GRID:grid.1005.4) (ISNI:0000 0004 4902 0432) 
7  University of New South Wales, Centre for Marine Bio-Innovation, Sydney, Australia (GRID:grid.1005.4) (ISNI:0000 0004 4902 0432); Nanyang Technological University, The Singapore Centre for Life Sciences Engineering and the School of Biological Sciences, Singapore, Singapore (GRID:grid.59025.3b) (ISNI:0000 0001 2224 0361) 
8  Royal Rehabilitation Centre Sydney, Sydney, Australia (GRID:grid.419366.f) (ISNI:0000 0004 0613 2733) 
9  Royal North Shore Hospital, Sydney, Australia (GRID:grid.412703.3) (ISNI:0000 0004 0587 9093) 
10  University of Technology Sydney, Centre for Health Economics Research and Evaluation [CHERE], Sydney, Australia (GRID:grid.117476.2) (ISNI:0000 0004 1936 7611) 
11  Kolling Institute, John Walsh Centre for Rehabilitation Research, St Leonards, Australia (GRID:grid.117476.2); University of Sydney, Sydney Medical School Northern, Sydney, Australia (GRID:grid.1013.3) (ISNI:0000 0004 1936 834X) 
Pages
550-561
Publication year
2019
Publication date
Jul 2019
Publisher
Nature Publishing Group
ISSN
13624393
e-ISSN
14765624
Source type
Scholarly Journal
Language of publication
English
DOI
https://doi.org/10.1038/s41393-019-0251-y
ProQuest document ID
2252670502
Copyright
This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.