Department of Obstetrics and Gynecology, Peking University Shenzhen Hospital
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Cure rate of BV
研究概览
简要总结
The investigators are trying to determine if oral Probiotics(Umeta-mimi,30 days) with Metronidazole vaginal suppositories (7 days) is better than using Metronidazole vaginal suppositories(7 days) only in preventing the recurrence of bacterial vaginosis
详细描述
Studies have shown that oral Probiotics(Umeta-mimi) can significantly promote the recovery of vaginal flora mainly because intestinal microbiota can migrate and affect vaginal microecology. This project aims to evaluate the efficacy of oral Probiotics(Umeta-mimi,30 days) with Metronidazole vaginal suppositories(7 days) in the treatment of bacterial vaginosis (BV) and to explore the correlation between vaginal flora and fecal flora by detecting the metagenomics of vaginal secretions and intestinal feces at the time of baseline phase,14 days after treatment， the first month after treatment, 5-7 days after third menstruation after treatment and 5-7 days after sixth menstruation after treatment
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Aged 18 to 55 years old, with history of sexual activity,
- •Amsel criterion for diagnosing BV
- •Sign informed consent
排除标准
- •History of systemic organic diseases or psychiatric diseases
- •Planning for or during pregnancy, lactation, menstruation
- •within 5 days of onset of the disease, any antibiotics has been used
- •Long-term use of contraceptives or immunosuppressant
- •Anaphylactic constitution or allergic to known ingredients of research drugs
- •No same fixed partner (RSP) before and after treatment
研究组 & 干预措施
Metronidazole vaginal
Metronidazole vaginal suppositories (200 mg,2 capsules per day,7 days )
干预措施: Metronidazole vaginal suppositories (Drug)
Metronidazole vagianl and Probiotics(Umeta-mimi)
Metronidazole:Metronidazole vaginal suppositories (200 mg,2 capsules per day,7 days ) Probiotics:Oral Umeta-mimi( 5×109cfu per day,30 days）
干预措施: Metronidazole vaginal suppositories and Probiotics(Umeta-mimi) (Drug)
结局指标
主要结局
Cure rate of BV
时间窗: 14 days after treatment
Assessments with different Units of Measure:clinical symptoms such as itching or burning; "fishy" smell; homogeneous thin vaginal discharge;Nugent score; pH\>4.5; clue cell.
次要结局
- Recurrence of BV(5-7 days after sixth menstruation after treatment)
研究者
Shangrong Fan
Professor of Dept of Obstetrics and Gynecology
Peking University Shenzhen Hospital