NCT03116789已完成不适用
Analysis of Ameliorative Effects of Oral Probiotics on Bacterial Vaginosis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Nugent Score
研究概览
简要总结
The purpose of this study is to analyze the ameliorative effects of oral probiotics on bacterial vaginosis.
详细描述
To analyze the oral Lactobacillus rhamnosus with Lactobacillus acidophilus or Lactobacillus rhamnosus with Lactobacillus plantarum could be ameliorative effects for 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
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Informed Consent Form.
- •Subjects with bacterial vaginosis and Nugent score as 4-10
- •Subjects in age of 20-55 years old
- •Regularly menstruating premenopausal women (normal menstrual function (Eumenorrhoea) shall mean regular menstrual bleeding pattern every 28 plus/minus 10 days)
- •Forbidden sexual behavior was required 72 hours before all visits
排除标准
- •Subjects are pregnant, lactating or planning to become pregnant.
- •Allergy to test products (raw material components included: Anhydrous glucose, Magnesium stearate, Fructooligosaccharides, Microcrystalline cellulose, Lactobacillus, etc.)
- •Bleeding from genital tract of unknown aetiology.
- •Congenital and acquired immunodeficiencies.
- •Mental illness
- •Malignant tumor
- •Application of NuvaRing hormonal contraceptive vaginal ring
- •Application of mechanical contraceptives, such as: diaphragms, intrauterine contraceptive insert, except condom
- •Application of hormonal preparations, such as: Vagifem, Ovestin and vaginal estrogens in reproductive period.
- •Mycotic vaginitis
- •Antibiotic(unless indicated by PI) and steroids therapy during this trial.
- •Use of oral or vaginal probiotic products (sachet, capsule, or tablet) four weeks before V
- •Participation in another clinical study.
结局指标
主要结局
Nugent Score
时间窗: 4 weeks
The degree of decline for Nugent score
次要结局
- Vaginal pH(4 weeks)
- Vaginal secretions microflora(4 weeks)
研究者
研究点 (2)
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