Randomized, Triple-blind, Parallel-group Study to Evaluate the Effect of Consuming a Lactobacillus Strain on the Prevention of Recurrent Vaginal Candidiasis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Recurrence of candidiasis events
研究概览
简要总结
The objective of this study is to evaluate the efficacy of the consumption of the one probiotic strain in the prevention of new vaginal candidiasis events in women with recurrent vaginal candidiasis. This is a preliminary study whose purpose is to know if this probiotic is effective in reducing the number of candidiasis events and / or increasing the time between possible relapses in women diagnosed with RVVC.
详细描述
Previous studies have demonstrated the effectiveness of certain probiotic strains in the treatment of vaginal candidiasis, alone or as an adjunct to antifungal treatments, as well as the effectiveness of a Lactobacillus strain as maintenance treatment after antifungal treatment to reduce the recurrence rate of candidiasis However, to date, no studies have evaluated the oral efficacy of a probiotic strain of Lactobacillus originally isolated from breast milk in the prevention of new vaginal yeast events in women with recurrent vaginal yeast infections.
The objective of this study is to evaluate the efficacy of the consumption of the one probiotic strain in the prevention of new vaginal candidiasis events in women with recurrent vaginal candidiasis. This is a preliminary study whose purpose is to know if this probiotic is effective in reducing the number of candidiasis events and / or increasing the time between possible relapses in women diagnosed with RVVC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy women from 18 to 49 years old.
- •Having suffered at least four outbreaks of vaginal yeast infection in the last year.
- •Signed Informed Consent Form.
- •Agree to provide the scheduled samples.
- •Agree to perform gynecological examinations
- •Agree to report candidiasis events that occur during the study.
- •Ability to complete surveys.
排除标准
- •Being currently consuming or having consumed a probiotic in the two weeks prior to the study.
- •Being under antibiotic treatment at the time of beginning the study.
- •Being under pharmacological treatment for the treatment of candidiasis.
- •Have an allergy to an antibiotic
结局指标
主要结局
Recurrence of candidiasis events
时间窗: 6 months
Total candidiasis events during intervention
Time between episodes
时间窗: 6 months
Days from baseline until candidiasis events
次要结局
- Microbiota of vaginal exudate(6 months)
- Gynecological examination(6 months)
- pH of vaginal discharge(6 months)
- Determination of Candida in vaginal exudate by culture analysis(6 months)
- Test of related clinical symptoms(6 months)
- Intensity of the related clinical symptoms(6 months)