Probiotics [LGG-BB12 or RC14-GR1] versus placebo as prophylaxis for urinary tract infection in persons with spinal cord injury [ProSCIUTTU]: a study protocol for a randomised controlled trial

Lee, BB; Toh, SL; Ryan, S; Simpson, JM; Clezy, K; Bossa, L; Rice, SA; Marial, O; Weber, G; Kaur, J; Boswell-Ruys, C; Goodall, S; Middleton, J; Tudehope, 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 study protocol for a randomised controlled trial

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

Marial, O Weber, G Kaur, J Boswell-Ruys, C Goodall, S

Middleton, J Tudehope, M Kotsiou, G

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Publication Type:: Journal Article
Citation:: BMC Urology, 2016, 16 (1)
Issue Date:: 2016-04-16

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Field	Value	Language
dc.contributor.author	Lee, BB	en_US
dc.contributor.author	Toh, SL	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, G	en_US
dc.contributor.author	Kaur, J	en_US
dc.contributor.author	Boswell-Ruys, C	en_US
dc.contributor.author	Goodall, S https://orcid.org/0000-0001-6611-6565	en_US
dc.contributor.author	Middleton, J	en_US
dc.contributor.author	Tudehope, M	en_US
dc.contributor.author	Kotsiou, G	en_US
dc.date.available	2016-03-28	en_US
dc.date.issued	2016-04-16	en_US
dc.identifier.citation	BMC Urology, 2016, 16 (1)	en_US
dc.identifier.uri	http://hdl.handle.net/10453/44035
dc.description.abstract	© 2016 Lee et al. Background: Urinary tract infections [UTIs] are very common in people with Spinal Cord Injury [SCI]. UTIs are increasingly difficult and expensive to treat as the organisms that cause them become more antibiotic resistant. Among the SCI population, there is a high rate of multi-resistant organism [MRO] colonisation. Non-antibiotic prevention strategies are needed to prevent UTI without increasing resistance. Probiotics have been reported to be beneficial in preventing UTIs in post-menopausal women in several in vivo and in vitro studies. The main aim of this study is to determine whether probiotic therapy with combinations of Lactobacillus reuteri RC-14 + Lactobacillus rhamnosus GR-1 [RC14-GR1] and/or Lactobacillus rhamnosus GG + Bifidobacterium BB-12 [LGG-BB12] are effective in preventing UTI in people with SCI compared to placebo. Method: This is a multi-site randomised double-blind double-dummy placebo-controlled factorial design study conducted in New South Wales, Australia. All participants have a neurogenic bladder as a result of spinal injury. Recruitment started in April 2011. Participants are randomised to one of four arms, designed for factorial analysis of LGG-BB12 and/or RC14-GR1 v Placebo. This involves 24 weeks of daily oral treatment with RC14-GR1 + LGG-BB12, RC14-GR1 + placebo, LGG-BB12 + placebo or two placebo capsules. Randomisation is stratified by bladder management type and inpatient status. Participants are assessed at baseline, three months and six months for Short Form Health Survey [SF-36], microbiological swabs of rectum, nose and groin; urine culture and urinary catheters for subjects with indwelling catheters. A bowel questionnaire is administered at baseline and three months to assess effect of probiotics on bowel function. The primary outcome is time from randomisation to occurrence of symptomatic UTI. The secondary outcomes are change of MRO status and bowel function, quality of life and cost-effectiveness of probiotics in persons with SCI. The primary outcome will be analysed using survival analysis of factorial groups, with Cox regression modelling to test the effect of each treatment while allowing for the other, assuming no interaction effect. Hazard ratios and Kaplan-Meier survival curves will be used to summarise results. Discussion: If these probiotics are shown to be effective in preventing UTI and MRO colonisation, they would be a very attractive alternative for UTI prophylaxis and for combating the increasing rate of antibiotic resistance after SCI. Trial registration: Australian New Zealand Clinical Trials Registry [ ACTRN 12610000512022 ]. Date of registration: 21 June 2010.	en_US
dc.relation	http://purl.org/au-research/grants/nhmrc/630448
dc.relation.ispartof	BMC Urology	en_US
dc.relation.isbasedon	10.1186/s12894-016-0136-8	en_US
dc.subject.classification	Urology & Nephrology	en_US
dc.subject.mesh	Humans	en_US
dc.subject.mesh	Bifidobacterium	en_US
dc.subject.mesh	Urinary Tract Infections	en_US
dc.subject.mesh	Spinal Cord Injuries	en_US
dc.subject.mesh	Proportional Hazards Models	en_US
dc.subject.mesh	Double-Blind Method	en_US
dc.subject.mesh	Probiotics	en_US
dc.subject.mesh	New South Wales	en_US
dc.subject.mesh	Lactobacillus reuteri	en_US
dc.subject.mesh	Lactobacillus rhamnosus	en_US
dc.subject.mesh	Urinary Bladder, Neurogenic	en_US
dc.subject.mesh	Kaplan-Meier Estimate	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 study protocol for a randomised controlled trial	en_US
dc.type	Journal Article
utslib.citation.volume	1	en_US
utslib.citation.volume	16	en_US
utslib.for	1103 Clinical Sciences	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	1	en_US
pubs.publication-status	Published	en_US
pubs.volume	16	en_US

Abstract:

© 2016 Lee et al. Background: Urinary tract infections [UTIs] are very common in people with Spinal Cord Injury [SCI]. UTIs are increasingly difficult and expensive to treat as the organisms that cause them become more antibiotic resistant. Among the SCI population, there is a high rate of multi-resistant organism [MRO] colonisation. Non-antibiotic prevention strategies are needed to prevent UTI without increasing resistance. Probiotics have been reported to be beneficial in preventing UTIs in post-menopausal women in several in vivo and in vitro studies. The main aim of this study is to determine whether probiotic therapy with combinations of Lactobacillus reuteri RC-14 + Lactobacillus rhamnosus GR-1 [RC14-GR1] and/or Lactobacillus rhamnosus GG + Bifidobacterium BB-12 [LGG-BB12] are effective in preventing UTI in people with SCI compared to placebo. Method: This is a multi-site randomised double-blind double-dummy placebo-controlled factorial design study conducted in New South Wales, Australia. All participants have a neurogenic bladder as a result of spinal injury. Recruitment started in April 2011. Participants are randomised to one of four arms, designed for factorial analysis of LGG-BB12 and/or RC14-GR1 v Placebo. This involves 24 weeks of daily oral treatment with RC14-GR1 + LGG-BB12, RC14-GR1 + placebo, LGG-BB12 + placebo or two placebo capsules. Randomisation is stratified by bladder management type and inpatient status. Participants are assessed at baseline, three months and six months for Short Form Health Survey [SF-36], microbiological swabs of rectum, nose and groin; urine culture and urinary catheters for subjects with indwelling catheters. A bowel questionnaire is administered at baseline and three months to assess effect of probiotics on bowel function. The primary outcome is time from randomisation to occurrence of symptomatic UTI. The secondary outcomes are change of MRO status and bowel function, quality of life and cost-effectiveness of probiotics in persons with SCI. The primary outcome will be analysed using survival analysis of factorial groups, with Cox regression modelling to test the effect of each treatment while allowing for the other, assuming no interaction effect. Hazard ratios and Kaplan-Meier survival curves will be used to summarise results. Discussion: If these probiotics are shown to be effective in preventing UTI and MRO colonisation, they would be a very attractive alternative for UTI prophylaxis and for combating the increasing rate of antibiotic resistance after SCI. Trial registration: Australian New Zealand Clinical Trials Registry [ ACTRN 12610000512022 ]. Date of registration: 21 June 2010.

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