Pilot Study to Observe Effects of Flourish HEC Vaginal Care System on Vaginal Microbiome in Women With Recurrent Bacterial Vaginosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Change in vaginal microbiome by next-generation sequencing (NGS)
研究概览
简要总结
In a population of women with heightened vulvovaginal sensitivity and recurrent bacterial vaginosis (BV), the use of the Flourish HEC Vaginal Care System is being tested for prevention of BV recurrence over six months of use.
详细描述
BV treated with metronidazole or clindamycin recurs within 3 months in at least 43% of women, requiring additional rounds of antibiotics. Preliminary data show that the use of a commercially available 3-component kit can dramatically reduce BV recurrence over 11 weeks of use. This study tests a similar kit with one component altered - the intravaginal gel is composed of hydroxyethylcellulose rather than aloe, making it less likely to trigger reactions in women with sensitive tissues. The study will examine recurrence of BV, vaginal pH, and vulvovaginal symptoms as in the prior study, though extended to 6 months. Additionally, this study examines changes in the vaginal microbiome using targeted next-generation sequencing with the use of the Flourish HEC system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 52 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pre-menopausal women between the ages of 18 and
- •Diagnosis of recurrent BV: >= 3 episodes of BV within last year, or >= 2 episodes of BV within past six months, recorded in medical record
- •Desire to use personal hygiene products to avoid recurrence of BV.
排除标准
- •Known allergy or sensitivity to any other ingredient in the Flourish HEC Vaginal Care System
- •Immunosuppressed or immunocompromised individuals
- •Known allergy or intolerability to metronidazole
- •Anyone who may have mental health disorders triggered by answering questions related to vulvar or vaginal health, by pelvic exams, or self-application of vaginal products
- •Known vaginal infection that is not BV or yeast infection
- •Adults unable to consent
- •Individuals who are not yet adults (infants, children, teenagers)
- •Pregnant women
- •Prisoners
结局指标
主要结局
Change in vaginal microbiome by next-generation sequencing (NGS)
时间窗: 3 months to 6 months
Vaginal swab will be analyzed by commercially available NGS service
BV recurrence
时间窗: 6 months
Percentage of women with recurrence of BV during the study after initial cure with routine care, if applicable
Change in vaginal microbiome by Nugent scoring
时间窗: 3 months to 6 months
Vaginal smear slide will be Gram stained and Nugent scored
次要结局
- Change in vaginal pH(3 months to 6 months)
- Change in vulvovaginal symptoms questionnaire (VSQ) self-report(3 months to 6 months)