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.
journal_name
Spinal Cordjournal_title
Spinal cordauthors
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 Gdoi
10.1038/s41393-019-0251-ysubject
Has Abstractpub_date
2019-07-01 00:00:00pages
550-561issue
7eissn
1362-4393issn
1476-5624pii
10.1038/s41393-019-0251-yjournal_volume
57pub_type
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