NCT04118049已完成不适用
The Effect of Vaginal Probiotics on the Vaginal Microenvironment in Patients Using Vaginal Pessaries: a Randomized Controlled Trial.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 141
- 试验地点
- 2
- 主要终点
- Change in vaginal microenvironment
研究概览
简要总结
In this study, the investigators are evaluating the effect of vaginal probiotics on the bothersome side effects of pessary use and the impact on the vaginal microenvironment (lactobacilli, anaerobic bacteria, mobiluncus bacteria, WBCs, cellular debris, epithelial cells, and BVAB-1), and inflammatory environment (cytokines).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
盲法说明
Investigators performing vaginal specimens are blinded to treatment arm.
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal (no menstruation >12 months)
- •Subjects presenting for 2 week post initial pessary insertion appointment or presenting for routine pessary care follow up appointment
- •Planning on continuing to use a pessary for treatment for at least 3 months
- •Pessary maintenance performed by provider (as opposed to self-care)
- •Able to understand English
- •Able/willing to sign informed consent document
排除标准
- •Lack of cognitive ability to consent to participate in study and to complete the questionnaires
- •Planned prolapse surgery less than 3 months from enrollment
- •Presence of vaginal fistulas
- •Pessary self-care (patient changes and cleans her own pessary)
- •Receiving immunosuppressive therapy or history of immunodeficiency
- •Presence of an indwelling vascular access line or structural heart disease
- •Within 6 weeks from any abdominal or pelvic surgery or other major surgery
- •Allergy to lactobacillus (contents of probiotic)
- •Allergy to beta-lactam antibiotics, erythromycin and clindamycin
- •Use of any probiotic pills, creams, or suppositories currently
结局指标
主要结局
Change in vaginal microenvironment
时间窗: Vaginal specimen assessment with gram stain will be assessed upon enrollment and after 3 months of treatment.
Change in vaginal microenvironment on gram stain measuring lactobacilli, anaerobic bacteria, and mobiluncus, WBCs and epithelial cell maturation reported as Nugent Subscore.
次要结局
- Vaginal probiotic feasibility, compliance with, and side effects of probiotic use.(Participants will complete after 1 month of use as well as at 3 months.)
- Pro-inflammatory cytokines (Interleukin (IL-6)), Tumor Necrosis Factor-alpha (TNF-alpha), Interleukin(IL-1alpha) and Interleukin (IL-1beta)(Vaginal specimens will be collected for cytokine analysis at enrollment and after 3 months)
- Pelvic Floor Disability Index (PFDI-20)(Participants will complete the PFDI-20 upon enrollment and after 3 months of treatment.)
- Incidence of adverse events (safety and tolerability)(from enrollment to 3 month follow up visit)
- Urinary tract infection incidence(During participant involvement in the study 3-4 months.)
- BVAB-1(Vaginal specimen will collect from participants upon enrollment and after 3 months.)
研究者
研究点 (2)
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