Evidence map›Paper›PMID 30814670›Full record

Trial reportSpinal cord2019

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.

Swee-Ling Toh, Bonsan Bonne Lee, Suzanne Ryan, Judy M Simpson, Kate Clezy, Laetitia Bossa, Scott Alan Rice, Obaydullah Marial, Gerard Hogan Weber, Jasbeer Kaur and 5 more

Abstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Spinal cord, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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  5. Article
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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

15 authors.

Swee-Ling TohDepartment of Spinal and Rehabilitation Medicine, Prince of Wales Hospital, Sydney, Australia. SweeLing.Toh@health.nsw.gov.au.
Bonsan Bonne LeeDepartment of Spinal and Rehabilitation Medicine, Prince of Wales Hospital, Sydney, Australia.
Suzanne RyanNeuroscience Research Australia [NeuRA] and the University of New South Wales, Sydney, Australia.
Judy M SimpsonSchool of Public Health, University of Sydney, Sydney, Australia.
Kate ClezyDepartment of Infectious Diseases, Prince of Wales Hospital, Sydney, Australia.
Laetitia BossaNeuroscience Research Australia [NeuRA] and the University of New South Wales, Sydney, Australia.
Scott Alan RiceCentre for Marine Bio-Innovation, University of New South Wales, Sydney, Australia.ORCID http://orcid.org/0000-0002-9486-2343
Obaydullah MarialNeuroscience Research Australia [NeuRA] and the University of New South Wales, Sydney, Australia.
Gerard Hogan WeberRoyal Rehabilitation Centre Sydney, Sydney, Australia.
Jasbeer KaurRoyal North Shore Hospital, Sydney, Australia.
Claire Louise Boswell-RuysDepartment of Spinal and Rehabilitation Medicine, Prince of Wales Hospital, Sydney, Australia.
Stephen GoodallCentre for Health Economics Research and Evaluation [CHERE], University of Technology Sydney, Sydney, Australia.
James Walter MiddletonJohn Walsh Centre for Rehabilitation Research, Kolling Institute, Northern Sydney Local Health District, St Leonards, NSW, 2065, Australia.
Mark TuderhopeRoyal North Shore Hospital, Sydney, Australia.
George KotsiouRoyal North Shore Hospital, Sydney, Australia.

Funding

Department of Health | National Health and Medical Research Council (NHMRC) 630448
6 · The paper itself

Abstract

STUDY

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

objectiveUrinary 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.

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

methodsWe 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.

resultsAnalysis 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.

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

Indexed as

ProbioticsAdultAgedAged, 80 and overDouble-Blind MethodFemaleHumansMaleMiddle AgedSpinal Cord InjuriesUrinary Tract InfectionsYoung Adult

Identifiers

PMID30814670
PMCPMC6760555

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Registered trials

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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.