Phase II Multicentered Randomized Open-label Study of Effectiveness and Safety of Lactofiltrum in Women With Bacterial Vaginosis
试验速览
- 阶段
- 2 期
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Self-reported complaints
研究概览
简要总结
This is a phase II multicenter randomized open-label clinical study that will determine whether treatment with Lactofiltrum (orally administered tablets) in combination with antibiotic therapy (metronidazole) is effective in women with bacterial vaginosis. Lactofiltrum is a composite drug that includes enterosorbent lignin and prebiotic Lactulose. It's supposed that supplement of Lactofiltrum to a standard therapy of bacterial vaginosis (metronidazole administered orally) improves women's general state, leads to better recovery of clinical, microbiological, biochemical and histological features of the disease.
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •bacterial vaginosis.
排除标准
- •pregnancy and breast-feeding;
- •concomitant infection diseases;
- •systemic or topical treatment with antibiotics, steroids, immunosuppressive, cytostatic or antimetabolite agents by the time of inclusion;
- •application of intravaginal medicines during participation in the study;
- •severe diseases;
- •renal and hepatic failure;
- •application of pre-, probiotics and antibiotics 2 weeks before inclusion or during participation in the study;
- •participation in other clinical study 1 month before inclusion or during participation in the proposed study.
研究组 & 干预措施
Lactofiltrum
干预措施: Lactofiltrum + Metronidazole (Drug)
Control
干预措施: Metronidazole (Drug)
结局指标
主要结局
Self-reported complaints
时间窗: Days 0, 14 and 44 after start of intervention
It's measured by seven ordinal (analog) scales (vaginal itch, vaginal burning, itch of external genitals, burning of external genitals, vaginal discharge, urination disorder,painful intercourse) with minimal value "0" (absent of the complaint-related discomfort) and maximal value "10" (maximal discomfort).
次要结局
- Microbiological examination of vaginal discharge(Days 0, 14 and 44 after start of intervention)
- pH-test of vaginal discharge(Days 0, 14 and 44 after start of intervention)
- Gynaecological examination(Days 0, 14 and 44 after start of intervention)
- Blood test(Days 0, 14 and 44 after start of intervention)
- Microscopy of vaginal discharge(Days 0, 14 and 44 after start of intervention)
- Microbiological feces analysis(Days 0, 14 and 44 after start of intervention)
- Urine test(Days 0, 14 and 44 after start of intervention)