Extended Antimicrobial Treatment of Bacterial Vaginosis Combined With Human Lactobacilli to Find the Best Treatment and Minimize the Risk of Relapses
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- characterize lactobacilli of human vaginal origin
研究概览
简要总结
The primary objectives of this study were to characterize lactobacilli of human vaginal origin and to investigate if more extended antibiotic treatment against Bacterial Vaginosis, together with adjuvant lactobacilli treatment, could increase the cure rate and furthermore, to investigate factors that could influence relapse.
详细描述
Nine of the vaginal Lactobacillus strains isolated from healthy Swedish women and characterized in the present study were selected for the clinical trial.All women with symptomatic BV fulfilling the inclusion criteria were consecutively offered to participate in a prospective study of adjuvant lactobacilli given in addition to antibiotics. Women included were regularly menstruating women, 18 years or older, with normal gynaecological status, not pregnant or breast-feeding and without signs of other genital tract infections. Exclusion criteria were patients with hormonal intrauterine device without regular menstruation; women infected with Chlamydia trachomatis or with Trichomonas vaginalis, or with a clinical candida infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •were regularly menstruating women, 18 years or older, with normal gynaecological status, not pregnant or breast-feeding and without signs of other genital tract infections.
排除标准
- •Exclusion criteria were patients with hormonal IUD without regular menstruation; women infected with Chlamydia trachomatis or with Trichomonas vaginalis, or with a clinical candida infection
研究组 & 干预措施
Lactobacilli
different lactobacilli.
干预措施: lactobacilli (Drug)
结局指标
主要结局
characterize lactobacilli of human vaginal origin
时间窗: 24 month
characterize lactobacilli of human vaginal origin
次要结局
- cure rate after 24 month(24 month)
研究者
Per-Goran Larsson
professor
Skaraborg Hospital