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
| Autor: | Swee-Ling Toh, Laetitia Bossa, Jasbeer Kaur, Bonsan B. Lee, O Marial, Stephen Goodall, Kate Clezy, Suzanne Ryan, Claire L. Boswell-Ruys, Scott A. Rice, Mark Tuderhope, Judy M. Simpson, George Kotsiou, Gerard Weber, James W. Middleton |
|---|---|
| Přispěvatelé: | School of Biological Sciences, Singapore Centre for Environmental Life Sciences and Engineering (SCELSE) |
| Jazyk: | angličtina |
| Rok vydání: | 2019 |
| Předmět: |
Adult
Male 030506 rehabilitation medicine.medical_specialty Urinary system Bladder Spinal cord diseases Placebo Article law.invention Young Adult 03 medical and health sciences 0302 clinical medicine Double-Blind Method Randomized controlled trial Lactobacillus rhamnosus Nutritional supplements law Internal medicine medicine Humans Young adult Spinal cord injury Spinal Cord Injuries Survival analysis Aged Aged 80 and over Intention-to-treat analysis biology business.industry Probiotics Rehabilitation Biological sciences [Science] Urological manifestations General Medicine Middle Aged medicine.disease biology.organism_classification 3. Good health Neurology Spinal Cord Urinary Tract Infections Randomized controlled trials Female Neurology (clinical) 0305 other medical science business 030217 neurology & neurosurgery |
| Zdroj: | Spinal Cord |
| Popis: | 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. Published version National Health and Medical Research Council (NHMRC) is the organisation responsible for funding the supply of probiotics and matching placebo selected by the researchers for this study and budgeted within the NHMRC grant. CHR Hansen, Horsholm, Denmark has been paid commercial rates for providing the intervention product and placebo. The company had no input into the design of the trial. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|