Verdenelli Maria Cristina, Cecchini Cinzia, Coman Maria Magdalena, Silvi Stefania, Orpianesi Carla, Coata Giuliana, Cresci Alberto, Di Renzo Gian Carlo
Synbiotec S.r.l., Spin-off of UNICAM, Via Gentile III Da Varano, 62032, Camerino, Italy.
School of Advanced Studies, University of Camerino, Camerino, Italy.
Curr Microbiol. 2016 Oct;73(4):483-90. doi: 10.1007/s00284-016-1085-x. Epub 2016 Jun 21.
The purpose of this study was to investigate whether vaginal administration of probiotic Lactobacillus results in their colonization and persistence in the vagina and whether it promotes normalization and maintenance of pH and Nugent score. A single-arm, open-label controlled towards the baseline (pre-post) study including 35 apparently healthy women was conducted. Each woman was examined three times during the study. Women were instructed to receive daily for 7 days, the probiotic suppositories SYNBIO(®) gin (Lactobacillus rhamnosus IMC 501(®) and Lactobacillus paracasei IMC 502(®)). Vaginal swabs were collected during visit 1, 2, and 3 to determine the total lactobacilli count, the presence of the two administered bacteria, the measure of the pH, and the estimation of Nugent score. Evaluation of treatment tolerability was based on analysis of the type and occurrence of adverse events. The probiotic vaginal suppository was well tolerated and no side effects were reported. Intermediate Nugent score was registered in 40 % of women at visit 1 and these intermediate scores reverted to normal at day 7 (end of treatment) in 20 % of subjects. Administration of SYNBIO(®) gin contributed to a significant increase in the lactobacilli level at visit 2. Molecular typing revealed the presence of the two strains originating from SYNBIO(®) gin in 100 % of women at visit 2 and 34 % at visit 3. No significant changes were registered for pH between visits. The SYNBIO(®) gin product is safe for daily use in healthy women and it could be useful to restore and maintain a normal vaginal microbiota.
本研究的目的是调查阴道给予益生菌乳酸杆菌是否会导致其在阴道内定植和持续存在，以及它是否能促进pH值和 Nugent评分的正常化和维持。进行了一项单臂、开放标签、以基线（前后）为对照的研究，纳入了35名表面健康的女性。在研究期间，每位女性接受了三次检查。指导女性连续7天每天使用益生菌栓剂SYNBIO(®) gin（鼠李糖乳杆菌IMC 501(®)和副干酪乳杆菌IMC 502(®)）。在第1、2和3次访视时收集阴道拭子，以确定总乳酸杆菌计数、两种给药细菌的存在情况、pH值测量以及Nugent评分估计。基于对不良事件的类型和发生情况的分析来评估治疗耐受性。益生菌阴道栓剂耐受性良好，未报告副作用。在第1次访视时，40%的女性Nugent评分为中等，其中20%的受试者在第7天（治疗结束时）这些中等评分恢复正常。在第2次访视时，给予SYNBIO(®) gin导致乳酸杆菌水平显著增加。分子分型显示，在第2次访视时，100%的女性存在源自SYNBIO(®) gin的两种菌株，在第3次访视时为34%。访视之间pH值没有显著变化。SYNBIO(®) gin产品对健康女性日常使用是安全的，它可能有助于恢复和维持正常的阴道微生物群。
