A Pilot Study of Efficacy and Safety of Oral Metronidazole Versus Oral Metronidazole With Lactobacillus Vaginal Suppositories to Prevent the Recurrence of Bacterial Vaginosis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Cure rate of BV
研究概览
简要总结
We are trying to determine if Oral Metronidazole with Lactobacillus Vaginal Suppositories is better than Oral Metronidazole in Preventing the Recurrence of Bacterial Vaginosis
详细描述
Bacterial vaginosis (BV) is the most prevalent cause of symptomatic vaginal discharge in the U.S. and has been associated with complications including preterm delivery of infants, pelvic inflammatory disease (PID), urinary tract infections (UTI) and acquisition/transmission of sexually transmitted diseases (STDs) including human immunodeficiency virus (HIV).
Control of BV has been advocated as a means of decreasing the prevalence of these complications. However, the etiology of BV remains unknown and the current treatment regimens are inadequate in terms of initial cure and recurrence rates.
Based on currently national guidelines by using oral metronidazole 400 BID for 7 days, a high recurrence rate of BV were reported.
We hypothesize that the Oral Metronidazole with Lactobacillus Vaginal Suppositories is better than Oral Metronidazole in Preventing the Recurrence of Bacterial Vaginosis
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 48 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women be at least 18 years of age
- •Have symptoms of vaginal odor and or/discharge
- •Meet the clinical (Amsel) criteria for BV
- •Willing to participate in research
排除标准
- •Presence of another vaginal infection or STD
- •Allergy to metronidazole
- •Pregnant or nursing
- •Use of oral or intravaginal antibiotics within the past 2 weeks
- •HIV or other chronic disease
- •Inability to keep return appointments
- •Contraindications for Lactobacillus Vaginal Suppositories（those without sexual history）
研究组 & 干预措施
Metronidazole Oral
Metronidazole Oral
干预措施: Metronidazole Oral (Drug)
"Metronidazole" and "Lactobacillus"
"Metronidazole" and "Lactobacillus"
干预措施: "Metronidazole" and "Lactobacillus" (Drug)
结局指标
主要结局
Cure rate of BV
时间窗: 4 weeks
Nugent score
次要结局
- Recurrence of BV(24 weeks)
研究者
Shangrong Fan
Profesor
Peking University Shenzhen Hospital