Swee-Ling Toh1,2, Bonsan Bonne Lee3,4, Judy M Simpson5, Scott A Rice6,7, George Kotsiou8, Obaydullah Marial4, Suzanne Ryan4. 1. Department of Spinal and Rehabilitation Medicine, Prince of Wales Hospital, Sydney, NSW, Australia. SweeLing.Toh@health.nsw.gov.au. 2. Sydney School of Public Health, University of Sydney, Sydney, NSW, Australia. SweeLing.Toh@health.nsw.gov.au. 3. Department of Spinal and Rehabilitation Medicine, Prince of Wales Hospital, Sydney, NSW, Australia. 4. Neuroscience Research Australia (NeuRA) and UNSW Sydney, Sydney, NSW, Australia. 5. Sydney School of Public Health, University of Sydney, Sydney, NSW, Australia. 6. Singapore Centre for Environmental Life Sciences Engineering and the School of Biological Sciences, Nanyang Technological University, Nanyang, Singapore. 7. The ithree Institute, University of Technology Sydney, Sydney, NSW, Australia. 8. Department of Infectious Diseases and Microbiology, NSW Health Pathology, Royal North Shore Hospital, Sydney, NSW, Australia.
Abstract
STUDY DESIGN: Randomised double-blind placebo-controlled trial. OBJECTIVES:Multi-resistant organism (MRO) colonisation is common in people with SCI. We aimed to determine whether Lactobacillus reuteriRC-14 + Lactobacillus GR-1 (RC14-GR1) and/or Lactobacillusrhamnosus GG + Bifidobacterium BB-12 (LGG-BB12) are effective in preventing or clearing MRO colonisation. SETTING: New South Wales, Australia. METHODS: The 207 SCI participants were randomised to one of four arms: (i) RC14-GR1 + LGG-BB12, (ii) RC14-GR1 + placebo, (iii) LGG-BB12 + placebo or (iv) double placebos for 6 months. Microbiological samples of nose, groin, urine and bowel were taken at baseline, 3 and 6 months. Analysis was conducted for the presence of methicillin-resistant Staphylococcus aureus (MRSA), multi-resistant gram-negative organisms (MRGNs) and vancomycin-resistant enterococcus (VRE). The outcomes were clearance of, or new colonisation with MRSA, MRGN, VRE or MROs and whether participants remained free of MRSA, MRGN, VRE or MROs throughout the study. Risk factors associated with an outcome were adjusted for using nominal or binary logistic regression. RESULTS: There was a significant reduction in new MRGN colonisation compared with placebo for participants treated with RC14-GR1 (OR 0.10, 95% CI, 0.01-0.88, P = 0.04), after allowing that inpatients were more likely to be newly colonised (OR 21.41, 95% CI, 3.98-115.13, P < 0.0001). Participants who intermittent self-catheterised (IMC) were more likely to remain MRO-free than those utilising SPC or IDCs (OR 2.80, 95% CI, 1.41-5.54, P = 0.009). CONCLUSIONS:Probiotics are ineffective at clearing MROs in people with SCI. However, RC14-GR1 is effective at preventing new colonisation with MRGNs. The use of IMC significantly improves the chance of remaining MRO-free.
RCT Entities:
STUDY DESIGN: Randomised double-blind placebo-controlled trial. OBJECTIVES: Multi-resistant organism (MRO) colonisation is common in people with SCI. We aimed to determine whether Lactobacillus reuteri RC-14 + Lactobacillus GR-1 (RC14-GR1) and/or Lactobacillus rhamnosus GG + Bifidobacterium BB-12 (LGG-BB12) are effective in preventing or clearing MRO colonisation. SETTING: New South Wales, Australia. METHODS: The 207 SCI participants were randomised to one of four arms: (i) RC14-GR1 + LGG-BB12, (ii) RC14-GR1 + placebo, (iii) LGG-BB12 + placebo or (iv) double placebos for 6 months. Microbiological samples of nose, groin, urine and bowel were taken at baseline, 3 and 6 months. Analysis was conducted for the presence of methicillin-resistant Staphylococcus aureus (MRSA), multi-resistant gram-negative organisms (MRGNs) and vancomycin-resistant enterococcus (VRE). The outcomes were clearance of, or new colonisation with MRSA, MRGN, VRE or MROs and whether participants remained free of MRSA, MRGN, VRE or MROs throughout the study. Risk factors associated with an outcome were adjusted for using nominal or binary logistic regression. RESULTS: There was a significant reduction in new MRGN colonisation compared with placebo for participants treated with RC14-GR1 (OR 0.10, 95% CI, 0.01-0.88, P = 0.04), after allowing that inpatients were more likely to be newly colonised (OR 21.41, 95% CI, 3.98-115.13, P < 0.0001). Participants who intermittent self-catheterised (IMC) were more likely to remain MRO-free than those utilising SPC or IDCs (OR 2.80, 95% CI, 1.41-5.54, P = 0.009). CONCLUSIONS: Probiotics are ineffective at clearing MROs in people with SCI. However, RC14-GR1 is effective at preventing new colonisation with MRGNs. The use of IMC significantly improves the chance of remaining MRO-free.