BACKGROUND Bacterial vaginosis affects 15 to 50% of women of reproductive age, and recurrence is common after treatment with an antibiotic agent. The high incidence of recurrence suggests the need for new treatments to prevent recurrent bacterial vaginosis. METHODS We conducted a randomized, double-blind, placebo-controlled, phase 2b trial to evaluate the ability of Lactobacillus crispatus CTV-05 (Lactin-V) to prevent the recurrence of bacterial vaginosis. Women 18 to 45 years of age who had received a diagnosis of bacterial vaginosis and who had completed a course of vaginal metronidazole gel as part of the eligibility requirements were randomly assigned, in a 2:1 ratio, to receive vaginally administered Lactin-V or placebo for 11 weeks; follow-up occurred through week 24. The primary outcome was the percentage of women who had a recurrence of bacterial vaginosis by week 12. RESULTS A total of 228 women underwent randomization: 152 to the Lactin-V group and 76 to the placebo group; of these participants, 88% in the Lactin-V group and 84% in the placebo group could be evaluated for the primary outcome. In the intention-to-treat population, recurrence of bacterial vaginosis by week 12 occurred in 46 participants (30%) in the Lactin-V group and in 34 participants (45%) in the placebo group (risk ratio after multiple imputation for missing responses, 0.66; 95% confidence interval [CI], 0.44 to 0.87; P = 0.01). The risk ratio for recurrence by week 24 (also calculated with multiple imputation for missing responses) was 0.73 (95% CI, 0.54 to 0.92). At the 12-week visit, L. crispatus CTV-05 was detected in 79% of participants in the Lactin-V group. The percentage of participants who had at least one adverse event related to Lactin-V or placebo by week 24 did not differ significantly between the groups. The percentage of participants with local or systemic adverse events was similar in the two groups. CONCLUSIONS The use of Lactin-V after treatment with vaginal metronidazole resulted in a significantly lower incidence of recurrence of bacterial vaginosis than placebo at 12 weeks. (Funded by the National Institutes of Health; ClinicalTrials.gov number, NCT02766023.).

中文翻译：

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Lactin-V预防细菌性阴道病复发的随机试验。

背景技术细菌性阴道病影响15至50％的育龄妇女，在用抗生素治疗后复发很常见。复发的高发生率表明需要采取新的治疗方法来预防复发性细菌性阴道病。方法我们进行了一项随机，双盲，安慰剂对照的2b期临床试验，以评估crispatatus crispatus CTV-05（Lactin-V）预防细菌性阴道病复发的能力。接受诊断为细菌性阴道病且已完成阴道甲硝唑凝胶疗程（作为资格要求的一部分）的18至45岁女性，按2：1的比例随机分配接受经阴道施用的Lactin-V或安慰剂11周；随访持续到第24周。主要结果是在第12周之前发生细菌性阴道病复发的女性百分比。结果共有228名女性接受了随机分组：Lactin-V组为152名，安慰剂组为76名；这些参与者中，Lactin-V组的88％和安慰剂组的84％可以评估主要结局。在意向性治疗人群中，Lactin-V组的46名参与者（30％）和安慰剂组的34名参与者（45％）到第12周时发生了细菌性阴道病复发（多次插补后遗漏的风险比）响应为0.66； 95％置信区间[CI]为0.44至0.87； P = 0.01）。到第24周时复发的风险比（也是通过对缺失的反应进行多次归因计算）为0.73（95％CI，0.54至0.92）。在12周的访问中，L。Lactin-V组中有79％的参与者检测到了crispatus CTV-05。两组之间至少有一种与乳素-V或安慰剂相关的不良事件的参与者的百分比在两组之间没有显着差异。两组中发生局部或全身不良事件的参与者百分比相似。结论阴道甲硝唑治疗后使用Lactin-V可使细菌性阴道病复发的发生率在12周时显着低于安慰剂。（由美国国立卫生研究院资助； ClinicalTrials.gov编号，NCT02766023。）。两组中发生局部或全身不良事件的参与者百分比相似。结论阴道甲硝唑治疗后使用Lactin-V可使细菌性阴道病复发的发生率在12周时显着低于安慰剂。（由美国国立卫生研究院资助； ClinicalTrials.gov编号，NCT02766023。）。两组中发生局部或全身不良事件的参与者百分比相似。结论阴道甲硝唑治疗后使用Lactin-V可使细菌性阴道病复发的发生率在12周时明显低于安慰剂。（由美国国立卫生研究院资助； ClinicalTrials.gov编号，NCT02766023。）。