Nuffield Department of Primary Care Health Sciences, Radcliffe Primary Care Bldg, University of Oxford, Oxford, United Kingdom.
Centre for Trials Research, Cardiff University, Heath Park, Cardiff, United Kingdom.
JAMA. 2020 Jul 7;324(1):47-56. doi: 10.1001/jama.2020.8556.
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.
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.
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.
The primary outcome was cumulative antibiotic administration days for all-cause infections measured from randomization for up to 1 year.
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.
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.
ISRCTN Identifier:16392920.
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，尽管益生菌是否能预防感染并减少这些环境中的抗生素使用的证据有限。
确定每日口服益生菌组合鼠李糖乳杆菌 GG 和动物双歧杆菌亚种乳双歧杆菌 BB-12 与安慰剂相比是否减少了养老院居民的抗生素使用。
设计、地点和参与者：这是一项 310 名年龄在 65 岁及以上的养老院居民的安慰剂对照随机临床试验，招募自英国 23 家养老院，于 2016 年 12 月至 2018 年 5 月间入组，最后一次随访时间为 2018 年 10 月 31 日。
研究参与者被随机分配接受每日胶囊，其中含有鼠李糖乳杆菌 GG 和动物双歧杆菌亚种乳双歧杆菌 BB-12 的益生菌组合（每个胶囊中的总细胞计数为 1.3×1010 至 1.6×1010）（n=155）或每日匹配的安慰剂（n=155），最长达 1 年。
主要结局是从随机分组开始至 1 年内所有原因感染的累积抗生素使用天数。
在 310 名随机分组的养老院居民中（平均年龄 85.3 岁；66.8%为女性），有 195 名（62.9%）居民仍然存活并完成了试验。参与者日记数据（包括研究产品使用、抗生素使用和感染迹象的每日数据）可用于 98.7%随机分配到益生菌组和 97.4%随机分配到安慰剂组的居民。随机分配到益生菌组的养老院居民的平均累积全身抗生素使用天数为 12.9 天（95%CI，0 至 18.05），随机分配到安慰剂组的居民的平均累积天数为 12.0 天（95%CI，0 至 16.95）（绝对差异，0.9 天[95%CI，-3.25 至 5.05]；调整发病率比，1.13[95%CI，0.79 至 1.63]；P=0.50）。共有 120 名养老院居民经历了 283 次不良事件（益生菌组 150 次，安慰剂组 133 次）。益生菌组中有 94 次事件导致住院，安慰剂组中有 78 次事件导致住院，益生菌组中有 33 次事件导致死亡，安慰剂组中有 32 次事件导致死亡。
在英国养老院居民中，每日剂量的鼠李糖乳杆菌 GG 和动物双歧杆菌亚种乳双歧杆菌 BB-12 益生菌组合并未显著减少所有原因感染的抗生素使用。这些发现不支持在该环境中使用益生菌。
ISRCTN 标识符：16392920。
