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 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.
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Data availability
Raw data and datasets generated or extracted are archived in NEURA for 15 years. More detailed extracted data can be found in Supplementary Table 3–5.
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Acknowledgements
The authors would like to thank other members of the ProSCIUTTU team—Dr Kate Clezy (KC), Dr Laetitia Bossa (LB), Dr Gerard Weber (GW), Dr Jasbeer Kaur (JK), Dr Claire Boswell-Ruys (CBR), Dr Stephen Goodall (SG), Dr James Middleton (JM), Mr Mark Tudehope (MT), Dr Marcella Kwan and Ms Elizabeth Rose.
Funding
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.
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Contributions
Trial protocol was developed by S-LT, BBL, JMS, OM, GK, SR, KC, GW, JK, CBR, SG, JM and MT over a series of teleconferences and workshops in Sydney, Australia in the late 2009 and early 2010 from an original study design developed by BBL and JMS. OM was responsible for designing and maintaining trial database. Data analysis was conducted by S-LT and checked by JMS. S-LT was responsible for initial manuscript preparation. All authors reviewed and were involved in writing up the final version of the manuscript prior to submission.
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BBL, JMS, SG and JM have received competitive research funding support from the NHMRC. BBL, CBR, JMS, KC and S-LT are also authors on the Cochrane review—probiotics for preventing UTI in people with neuropathic bladder. The Coloplast company has provided nursing support to several of BBL’s community patients with recurrent UTIs from January 2018 to July 2019 and continues to provide occasional community support to some of these patients. However, Coloplast has had no financial or editorial input into the design, analysis or write up of this trial. The rest of the authors have no competing financial or non-financial interests.
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Toh, SL., Lee, B.B., Simpson, J.M. et al. Effect of probiotics on multi-resistant organism colonisation in persons with spinal cord injury: secondary outcome of ProSCIUTTU, a randomised placebo-controlled trial. Spinal Cord 58, 755–767 (2020). https://doi.org/10.1038/s41393-020-0420-z
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DOI: https://doi.org/10.1038/s41393-020-0420-z
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