NCT03187457已完成不适用
PreFem: "What Happens to the Vaginal Microbiota When a BV Infection is Treated With Metronidazole?"
Danisco2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年9月4日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in vaginal microbiota assessed with sequencing
研究概览
简要总结
The study will assess vaginal microbiota levels before and after antibiotic treatment in females infected with Bacterial Vaginosis (BV).
详细描述
This method validation study will endeavour to obtain evidence for:
- Recruitment methodology effectiveness
- The usefulness of the "Canestest" test as a screening tool
- The time required for the vaginal microbiota (particularly Lactobacillus count) to return to normal after treatment of BV infection with metronidazole.
- The time required for the Nugent Score to return to normal after treatment of BV infection with metronidazole.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent
- •Female gender
- •Over 18 years of age
- •Have a high probability for compliance with and completion of the study
排除标准
- •Hypersensitivity to metronidazole --only applies to Group
- •Post-menopausal defined as at least 12 consecutive months without menstruation
- •Treatment of BV in last 4 weeks
- •Clinically significant menstrual irregularities
- •Suspected presence of STDs or other vaginal infection
- •Pregnancy
- •Breast feeding
- •Participation in other clinical studies which could influence genitourinary tract microbiota
- •Substance abuse
- •Investigator believes that the participant may be uncooperative and/or noncompliant and should therefore not participate in the study
研究组 & 干预措施
Control group
Other
Healthy women without Bacterial Vaginosis and without treatment
干预措施: Control: no treatment (Other)
Treatment group
Other
Metronidazole 400 mg 3 times daily for 5 days for Bacterial Vaginosis (BV) infection
干预措施: Metronidazole (Other)
结局指标
主要结局
Change in vaginal microbiota assessed with sequencing
时间窗: Baseline, at day 8, and at day 15
Change in vaginal microbiota is assessed with sequencing at 3 time points (baseline, at day 8 and at day 15 time points post antibiotic treatment.)
次要结局
- Vaginal microbiota/lactobacilli levels with Nugent scoring(Baseline, at day 8, and at day 15)
- Diagnosis of BV with "Canestest"(Baseline)
研究者
研究点 (2)
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