NCT03923985已完成不适用
Clinical Trial to Evaluate the Effect of an Oral Probiotic (Food Supplement) Containing Lactobacillus Crispatus on the Vaginal Flora
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Changes in the number of Lactobacillus Crispatus on the vaginal flora
研究概览
简要总结
Clinical trial to evaluate the effect of a probiotic containing Lactobacillus Crispatus on the vaginal flora
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy women between 18 and 45 years old
- •Women without current symptoms of vaginal infection
- •Negative bacteriological and clinical examination
排除标准
- •Women with vaginal infection
- •Women with undiagnosed vaginal bleeding
- •Patients with endometrial hyperplasia
- •Suspicion of neoplasia or active neoplasia
- •Women with intolerance, allergy or hypersensitivity to the components of the probiotic
- •Women with immunosuppressive disorders or with HIV
- •Women who are currently using probiotics by any route of administration
- •Women who are using some treatment for vaginal sepsis
- •Chronic decompensated noncommunicable diseases (diabetes mellitus, heart disease ...)
- •Pregnant women or those with precocious menopause
研究组 & 干预措施
Active Arm
Active Comparator
1 tablet / day of probiotic containing 10 Mld L. crispatus during two months
干预措施: Probiotic containing Lactobacillus Crispatus (Dietary Supplement)
Control Arm
No Intervention
No treatment
结局指标
主要结局
Changes in the number of Lactobacillus Crispatus on the vaginal flora
时间窗: Screening, month 2
Analysis of vaginal lactobacilli.
次要结局
- Changes in vaginal PH(Screening, month 2)
研究者
研究点 (1)
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