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.

中文翻译：

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益生菌对脊髓损伤患者多耐药生物定植的影响：ProSCIUTTU的次要结果，一项随机安慰剂对照试验。

研究设计随机双盲安慰剂对照试验。目的多耐药生物（MRO）定植在SCI患者中很常见。我们旨在确定罗伊氏乳杆菌RC-14 +乳杆菌GR-1（RC14-GR1）和/或鼠李糖乳杆菌GG +双歧杆菌BB-12（LGG-BB12）是否有效预防或清除MRO定植。地点澳大利亚新南威尔士州。方法将207名SCI参与者随机分为以下四个组之一：（i）RC14-GR1 + LGG-BB12，（ii）RC14-GR1 +安慰剂，（iii）LGG-BB12 +安慰剂，或（iv）双重安慰剂治疗6个月。在基线，3个月和6个月时采集鼻子，腹股沟，尿液和肠的微生物学样本。进行了耐甲氧西林金黄色葡萄球菌（MRSA）的分析，多重耐药的革兰氏阴性菌（MRGN）和耐万古霉素的肠球菌（VRE）。结果是清除或重新定殖了MRSA，MRGN，VRE或MRO，并且在整个研究过程中参与者是否仍然没有MRSA，MRGN，VRE或MRO。使用标称或二元逻辑回归对与结果相关的风险因素进行了调整。结果在允许住院患者更可能被新定殖之后，与接受安慰剂治疗的受试者相比，接受RC14-GR1治疗的受试者的新MRGN定植显着减少（OR 0.10、95％CI，0.01-0.88，P = 0.04）。 21.41，95％CI，3.98-115.13，P <0.0001）。与使用SPC或IDC的参与者相比，间歇性自我导管（IMC）的参与者更有可能保持无MRO的优势（OR 2.80、95％CI，1.41-5.54，P = 0.009）。结论益生菌不能清除SCI患者的MRO。但是，RC14-GR1可以有效地防止新的MRGN定植。使用IMC可以显着提高保持无MRO的机会。