BACKGROUND Antibiotic-associated diarrhoea (AAD) is a side-effect of antibiotic consumption and probiotics have been shown to reduce AAD. METHODS We conducted a multicentre, double-blind, placebo-controlled, randomised trial to evaluate the role of L. casei DN114001 (combined as a drink with two regular yoghurt bacterial strains) in reducing AAD and C. difficile infection in patients aged over 55 years. The primary outcome was the incidence of AAD during 2 weeks follow up. RESULTS 1127 patients, (mean age + SD 73.6 + 10.5), were randomised to the active group (n=549) or placebo group (n=577). Both groups were followed up as per protocol. Patients experiencing AAD during follow-up was 19.3% (106/549) in probiotic group vs 17.9% (103/577) in placebo group (unadjusted OR 1.10, 95% CI 0.82 - 1.49, p = 0.53). CONCLUSIONS We did not find any significant evidence of a beneficial effect of the specific probiotic formulation in preventing AAD in this elderly population drawn from a number of different UK hospitals. However, in the UK and in many other healthcare systems there have, in recent years, been many changes in antibiotic stewardship policies, an overall decrease in incidence in C. difficile infection, as well as an increased awareness of infection prevention, and modifications in nursing practice. In the light of these factors, it is impossible to conclude definitively from the current trial that the study- specific probiotic formulation has no role in preventing AAD, and it is our view that further trials may be indicated, controlling for these variables.

中文翻译：

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益生菌能预防与抗生素有关的腹泻吗？多中心随机安慰剂对照试验的结果。

背景技术抗生素相关性腹泻（AAD）是抗生素消耗的副作用，并且益生菌已显示减少AAD。方法我们进行了一项多中心，双盲，安慰剂对照的随机试验，以评估干酪乳杆菌DN114001（与两种常规酸奶菌种同时饮用）在降低55岁以上患者的AAD和艰难梭菌感染中的作用。年份。主要结局是随访2周内AAD的发生率。结果1127名患者（平均年龄+ SD 73.6 + 10.5）被随机分为活动组（n = 549）或安慰剂组（n = 577）。两组均按照方案随访。益生菌组随访期间发生AAD的患者为19.3％（106/549），而安慰剂组为17.9％（103/577）（未调整OR 1.10，95％CI 0.82-1.49，p = 0.53）。结论我们没有发现任何明显的证据表明特定益生菌制剂对预防来自英国多家不同医院的老年人群中AAD的有益作用。但是，近年来，在英国和许多其他医疗保健系统中，抗生素管理政策发生了许多变化，艰难梭菌感染的发生率总体下降，并且人们对感染预防的认识提高了，护理实践。鉴于这些因素，不可能从当前试验中明确得出研究特异性益生菌制剂对预防AAD的作用，我们认为可以指示进一步的试验来控制这些变量。