Importance Probiotics are frequently used by residents in care homes (residential homes or nursing homes that provide residents with 24-hour support for personal care or nursing care), although the evidence on whether probiotics prevent infections and reduce antibiotic use in these settings is limited. Objective To determine whether a daily oral probiotic combination of Lactobacillus rhamnosus GG and Bifidobacterium animalis subsp lactis BB-12 compared with placebo reduces antibiotic administration in care home residents. Design, Setting, and Participants Placebo-controlled randomized clinical trial of 310 care home residents, aged 65 years and older, recruited from 23 care homes in the United Kingdom between December 2016 and May 2018, with last follow-up on October 31, 2018. Interventions Study participants were randomized to receive a daily capsule containing a probiotic combination of Lactobacillus rhamnosus GG and Bifidobacterium animalis subsp lactis BB-12 (total cell count per capsule, 1.3 × 1010 to 1.6 × 1010) (n = 155), or daily matched placebo (n = 155), for up to 1 year. Main Outcomes and Measures The primary outcome was cumulative antibiotic administration days for all-cause infections measured from randomization for up to 1 year. Results Among 310 randomized care home residents (mean age, 85.3 years; 66.8% women), 195 (62.9%) remained alive and completed the trial. Participant diary data (daily data including study product use, antibiotic administration, and signs of infection) were available for 98.7% randomized to the probiotic group and 97.4% randomized to placebo. Care home residents randomized to the probiotic group had a mean of 12.9 cumulative systemic antibiotic administration days (95% CI, 0 to 18.05), and residents randomized to placebo had a mean of 12.0 days (95% CI, 0 to 16.95) (absolute difference, 0.9 days [95% CI, -3.25 to 5.05]; adjusted incidence rate ratio, 1.13 [95% CI, 0.79 to 1.63]; P = .50). A total of 120 care home residents experienced 283 adverse events (150 adverse events in the probiotic group and 133 in the placebo group). Hospitalizations accounted for 94 of the events in probiotic group and 78 events in the placebo group, and deaths accounted for 33 of the events in the probiotic group and 32 of the events in the placebo group. Conclusions and Relevance Among care home residents in the United Kingdom, a daily dose of a probiotic combination of Lactobacillus rhamnosus GG and Bifidobacterium animalis subsp lactis BB-12 did not significantly reduce antibiotic administration for all-cause infections. These findings do not support the use of probiotics in this setting. Trial Registration ISRCTN Identifier:16392920.

中文翻译：

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益生菌使用对疗养院居民抗生素使用的影响

重要性 益生菌经常被养老院（为居民提供 24 小时个人护理或护理支持的养老院或疗养院）的居民使用，尽管关于益生菌是否在这些环境中预防感染和减少抗生素使用的证据有限。目的 确定与安慰剂相比，鼠李糖乳杆菌 GG 和动物双歧杆菌乳酸亚种 BB-12 的每日口服益生菌组合是否会减少养老院居民的抗生素施用。设计、设置和参与者 安慰剂对照随机临床试验，在 2016 年 12 月至 2018 年 5 月期间从英国 23 家养老院招募了 310 名年龄在 65 岁及以上的养老院居民，最后一次随访时间为 2018 年 10 月 31 日. 干预 研究参与者随机接受含有鼠李糖乳杆菌 GG 和动物双歧杆菌乳酸亚种 BB-12 益生菌组合的每日胶囊（每个胶囊的总细胞计数，1.3 × 1010 至 1.6 × 1010）（n = 155），或每日匹配安慰剂（n = 155），长达 1 年。主要结果和指标 主要结果是从随机化至长达 1 年的全因感染累积抗生素给药天数。结果 在 310 名随机护理之家居民（平均年龄 85.3 岁；66.8% 为女性）中，195 名 (62.9%) 仍然活着并完成了试验。98.7% 随机分配到益生菌组的参与者和 97.4% 随机分配到安慰剂组的参与者日记数据（包括研究产品使用、抗生素施用和感染迹象在内的每日数据）可用。随机分配到益生菌组的疗养院居民的平均累积全身抗生素给药天数为 12.9 天（95% CI，0 至 18.05），随机分配至安慰剂的居民平均为 12.0 天（95% CI，0 至 16.95）（绝对值）差异，0.9 天 [95% CI，-3.25 至 5.05]；调整后发病率比率，1.13 [95% CI，0.79 至 1.63]；P = .50）。共有 120 名护理院居民经历了 283 次不良事件（益生菌组 150 次不良事件，安慰剂组 133 次）。住院占益生菌组的 94 起事件和安慰剂组的 78 起事件，死亡占益生菌组的 33 起事件和安慰剂组的 32 起事件。结论和相关性在英国养老院居民中，鼠李糖乳杆菌 GG 和动物双歧杆菌乳酸亚种 BB-12 的益生菌组合的日剂量不会显着减少全因感染的抗生素给药。这些发现不支持在这种情况下使用益生菌。试用注册 ISRCTN 标识符：16392920。