Abstract
BackgroundBacterial vaginosis (BV) is the most common vaginal syndrome among women in their reproductive years. It is associated with an increased risk of acquiring sexually transmitted infections and complications like preterm labor. BV is characterized by a high recurrence rate for which biofilms frequently found on vaginal epithelial cells may be a reason.ResultsHere, we report a controlled randomized clinical trial that tested the safety and effectiveness of a newly developed pessary containing an amphoteric tenside (WO3191) to disrupt biofilms after metronidazole treatment of BV. Pessaries containing lactic acid were provided to the control group, and microbial community composition was determined via Illumina sequencing of the V1-V2 region of the 16S rRNA gene. The most common community state type (CST) in healthy women was characterized by Lactobacillus crispatus. In BV, diversity was high with communities dominated by either Lactobacillus iners, Prevotella bivia, Sneathia amnii, or Prevotella amnii. Women with BV and proven biofilms had an increased abundance of Sneathia sanguinegens and a decreased abundance of Gardnerella vaginalis. Following metronidazole treatment, clinical symptoms cleared, Nugent score shifted to Lactobacillus dominance, biofilms disappeared, and diversity (Shannon index) was reduced in most women. Most of the patients responding to therapy exhibited a L. iners CST. Treatment with WO 3191 reduced biofilms but did not prevent recurrence. Women with high diversity after antibiotic treatment were more likely to develop recurrence.ConclusionsStabilizing the low diversity healthy flora by promoting growth of health-associated Lactobacillus sp. such as L. crispatus may be beneficial for long-term female health.Trial registrationClinicalTrials.gov NCT02687789
Highlights
Bacterial vaginosis (BV) is the most common vaginal syndrome among women in their reproductive years
The two most common ones are dominated by L. crispatus and L. iners, but community state type (CST) dominated by L. gasseri and L. jensenii
Categorical data were displayed separately for each treatment group using absolute frequencies and percentages (%) and time-to-event data were described by medians and quartiles calculated by Kaplan-Meier life-table methods [44]
Summary
Bacterial vaginosis (BV) is the most common vaginal syndrome among women in their reproductive years. It is associated with an increased risk of acquiring sexually transmitted infections and complications like preterm labor. The two most common ones are dominated by L. crispatus and L. iners, but CSTs dominated by L. gasseri and L. jensenii, Bacterial vaginosis (BV) is the most common vaginal syndrome in women of childbearing age, with a prevalence of 30% in Caucasian women [6] which are the majority of study participants analyzed here. BV is associated with a higher risk of acquiring sexually transmitted infections such as HIV, as well as miscarriage and preterm birth [4]. BV has a 60% rate of recurrence in the 12 months after treatment with the standard of care antibiotic metronidazole [8]
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