Department of Obstetrics and Gynecology, Peking University Shenzhen Hospital
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Number of Participants With Related Clinical Signs or Symptoms at Baseline
研究概览
简要总结
The investigators are trying to determine if oral probiotics (Umeta-Miyue, Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14) (30 days)with metronidazole vaginal suppositories(7 days) is better than using metronidazole vaginal suppositories only in preventing the recurrence of bacterial vaginosis (BV).
详细描述
Studies have shown that oral probiotics 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-Miyue, Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14) (30 days) with metronidazole vaginal suppositories(7 days) in the treatment of bacterial vaginosis 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, the first month after treatment, the third month after treatment and the sixth month 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 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Aged 18 to 65 years old, with history of sexual activity, premenopausal women；
- •Nugent Score ≥ 7 for diagnosing BV；
- •Sign informed consent.
排除标准
- •mixed vaginitis, such as vulvovaginal candidiasis (VVC), Trichomonas vaginalis (TV) infection, Chlamydia trachomatis (CT) infection or gonococcal vaginitis;
- •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.
研究组 & 干预措施
Probiotics and Metronidazole
Probiotics: Oral probiotics(Umeta-Miyue, Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14) ) (qd, 30 days); Metronidazole: Metronidazole vaginal suppositories (qd,7 days)
干预措施: "Probiotics" and "Metronidazole" (Drug)
Metronidazole vaginal
Metronidazole vaginal suppositories(1 suppositories,qd,7 days )
干预措施: Metronidazole Vaginal (Drug)
结局指标
主要结局
Number of Participants With Related Clinical Signs or Symptoms at Baseline
时间窗: 1 day before starting treatment
Clinical signs and symptoms of bacteria vaginosis (BV), including homogeneous and thin vaginal discharge, unpleasant odour (such as a "fishy" smell) and vulvar discomfort (such as itching or burning), were recorded at baseline, the number of participants with related clinical signs or symptoms at Baseline were calculated.
Number of Participants With Clinically Effective in Each Study Arm in the 30-day Follow-up
时间窗: the 30th day after starting treatment
Clinical signs and symptoms of BV, including homogeneous and thin vaginal discharge, unpleasant odour (such as a "fishy" smell) and vulvar discomfort (such as itching or burning), were recorded at the 30-day, the number of participants with clinically effective (with the sign or symptoms disappeared or released compared with the baseline data) were calculated.
Number of Participants With Clinically Effective in Each Study Arm at the 90-day Follow-up
时间窗: the 90th day after starting treatment
Clinical signs and symptoms of BV, including homogeneous and thin vaginal discharge, unpleasant odour (such as a "fishy" smell) and vulvar discomfort (such as itching or burning), were recorded at the 30-day, the number of participants with clinically effective (with the sign or symptoms disappeared or released compared with the 30-day follow-up data) were calculated.
Number of Participants With Bacteriological Cure in Each Study Arm at the 30-day Follow-up
时间窗: the 30th day after starting treatment
A vaginal swab for bacteriological assessment of BV by Nugent criteria was performed. The Nugent score can range from 0 to 10. Bacteriological cure of BV was defined as a normal Nugent score of 0-6. Participants who were clinical failures, or had a Nugent score ≥ 7 were therapeutic failures.
Number of Participants With Bacteriological Cure in Each Study Arm at the 90-day Follow-up
时间窗: the 90th day after starting treatment
A vaginal swab for bacteriological assessment of BV by Nugent criteria was performed. The Nugent score can range from 0 to 10. Bacteriological cure of BV was defined as a normal Nugent score of 0-6. Participants who were clinical failures, or had a Nugent score ≥ 7 were therapeutic failures.
次要结局
未报告次要终点
研究者
Shangrong Fan
Departmemt of Obstetrics and Gynecology
Peking University Shenzhen Hospital