1 Competence Centre on Health Technologies, Tiigi 61B, Tartu 50410, Estonia.
2 Department of Microbiology, Institute of Biomedicine and Translational Medicine, University of Tartu, Ravila 19, Tartu 50411, Estonia.
Benef Microbes. 2019 Apr 19;10(4):385-393. doi: 10.3920/BM2016.0123. Epub 2019 Mar 18.
Vaginal discharge is one of the common reasons for gynaecologist consultation, as bacterial vaginosis and candidiasis are the main causes of discharge. These patients frequently experience numerous problems due to recurrent infections, side effects and drug resistance therefore alternative drugs are needed. Our primary aim was to evaluate safety and tolerability of the potentially probiotic strains in volunteer women considering themselves healthy. We also monitored the effects of these strains on vaginal health parameters and lactobacilli counts in vagina and intestine. Forty women were recruited into trial. Absence of chronic diseases was confirmed by questionnaire and blood analysis at screening visit. In randomised double-blind placebo-controlled crossover study the eligible participants were randomly allocated to one of four groups and had to consume one of the two study products (Pro I or Pro II) - a capsule containing 3 strains, 10 cfu per strain, or placebo for 1 week. Treatment period was followed by 2-week washout period and continued with second treatment and washout period. Individuals receiving firstly probiotic, received later placebo and . Blood, vaginal and faecal samples were collected, and self-reported questionnaires were applied. Thirty subjects completed the trial. The probiotic capsules were well-tolerated. The Pro II intake resulted in a significant decrease in Nugent score (from median 3.0 to 2.0, mean 3.9 to 2.6, =0.002) and reduction in counts (log 3.57 to 2.38; =0.027). Reduction of total vaginal bacterial counts was revealed in Pro I group (log 7.99 to 7.72; =0.048). In conclusion, the selected vaginal strains are well tolerable and Pro II mixture is prospectively effective in reducing Nugent score and vaginal counts of . Therefore, these strains seem to be promising candidates for development of novel evidence-based well-focused probiotics to target female urogenital tract disorders.
阴道分泌物是妇科就诊的常见原因之一,细菌性阴道病和念珠菌病是导致分泌物的主要原因。这些患者由于反复感染、副作用和耐药性而经常出现许多问题,因此需要替代药物。我们的主要目的是评估被认为健康的志愿者女性中潜在益生菌菌株的安全性和耐受性。我们还监测了这些菌株对阴道健康参数和阴道和肠道中乳杆菌计数的影响。共有 40 名女性入组试验。在筛选访问时通过问卷和血液分析确认无慢性疾病。在随机、双盲、安慰剂对照交叉研究中,合格的参与者被随机分配到四组中的一组,并服用两种研究产品之一(Pro I 或 Pro II)- 一种含有 3 株的胶囊,每株 10cfu ,或安慰剂,持续 1 周。治疗期后进行 2 周洗脱期,然后继续进行第二次治疗和洗脱期。首先接受益生菌的个体后来接受安慰剂。采集血液、阴道和粪便样本,并应用自我报告问卷。30 名受试者完成了试验。益生菌胶囊耐受性良好。Pro II 摄入可显著降低 Nugent 评分(中位数从 3.0 降至 2.0,平均值从 3.9 降至 2.6,=0.002)和 计数减少(对数 3.57 至 2.38;=0.027)。Pro I 组总阴道细菌计数减少(对数 7.99 至 7.72;=0.048)。总之,所选阴道菌株耐受性良好,Pro II 混合物有望有效降低 Nugent 评分和阴道 计数。因此,这些菌株似乎是开发针对女性泌尿生殖系统疾病的新型基于证据的有针对性益生菌的有前途的候选者。