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

Toh, SL; Lee, BB; Ryan, S; Simpson, JM; Clezy, K; Bossa, L; Rice, SA; Marial, O; Weber, GH; Kaur, J; Boswell-Ruys, CL; Goodall, S; Middleton, JW; Tuderhope, M; Kotsiou, G

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

Toh, SL Lee, BB Ryan, S Simpson, JM Clezy, K Bossa, L Rice, SA

Marial, O Weber, GH Kaur, J Boswell-Ruys, CL Goodall, S

Middleton, JW Tuderhope, M Kotsiou, G

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Publication Type:: Journal Article
Citation:: Spinal Cord, 2019, 57 (7), pp. 550 - 561
Issue Date:: 2019-07-01

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Field	Value	Language
dc.contributor.author	Toh, SL	en_US
dc.contributor.author	Lee, BB	en_US
dc.contributor.author	Ryan, S	en_US
dc.contributor.author	Simpson, JM	en_US
dc.contributor.author	Clezy, K	en_US
dc.contributor.author	Bossa, L	en_US
dc.contributor.author	Rice, SA https://orcid.org/0000-0002-9486-2343	en_US
dc.contributor.author	Marial, O	en_US
dc.contributor.author	Weber, GH	en_US
dc.contributor.author	Kaur, J	en_US
dc.contributor.author	Boswell-Ruys, CL	en_US
dc.contributor.author	Goodall, S https://orcid.org/0000-0001-6611-6565	en_US
dc.contributor.author	Middleton, JW	en_US
dc.contributor.author	Tuderhope, M	en_US
dc.contributor.author	Kotsiou, G	en_US
dc.date.available	2019-01-14	en_US
dc.date.issued	2019-07-01	en_US
dc.identifier.citation	Spinal Cord, 2019, 57 (7), pp. 550 - 561	en_US
dc.identifier.issn	1362-4393	en_US
dc.identifier.uri	http://hdl.handle.net/10453/131774
dc.description.abstract	© 2019, The Author(s). 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.	en_US
dc.relation	http://purl.org/au-research/grants/nhmrc/630448
dc.relation.ispartof	Spinal Cord	en_US
dc.relation.isbasedon	10.1038/s41393-019-0251-y	en_US
dc.subject.classification	Rehabilitation	en_US
dc.subject.mesh	Humans	en_US
dc.subject.mesh	Urinary Tract Infections	en_US
dc.subject.mesh	Spinal Cord Injuries	en_US
dc.subject.mesh	Double-Blind Method	en_US
dc.subject.mesh	Probiotics	en_US
dc.subject.mesh	Adult	en_US
dc.subject.mesh	Aged	en_US
dc.subject.mesh	Aged, 80 and over	en_US
dc.subject.mesh	Middle Aged	en_US
dc.subject.mesh	Female	en_US
dc.subject.mesh	Male	en_US
dc.subject.mesh	Young Adult	en_US
dc.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	en_US
dc.type	Journal Article
utslib.citation.volume	7	en_US
utslib.citation.volume	57	en_US
utslib.for	1103 Clinical Sciences	en_US
utslib.for	1106 Human Movement and Sports Sciences	en_US
utslib.for	1109 Neurosciences	en_US
pubs.embargo.period	Not known	en_US
pubs.organisational-group	/University of Technology Sydney
pubs.organisational-group	/University of Technology Sydney/Faculty of Business
pubs.organisational-group	/University of Technology Sydney/Faculty of Science
pubs.organisational-group	/University of Technology Sydney/Strength - CHERE - Centre for Health Economics Research and Evaluation
pubs.organisational-group	/University of Technology Sydney/Strength - ithree - Institute of Infection, Immunity and Innovation
utslib.copyright.status	open_access
pubs.issue	7	en_US
pubs.publication-status	Published	en_US
pubs.volume	57	en_US

Abstract:

© 2019, The Author(s). 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.

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http://hdl.handle.net/10453/131774