NCT02345096终止不适用
A Randomized, Double-blind, Placebo Controlled Study to Evaluate the Effect of Saccharomyces Cerevisiae on Improving the Effectiveness of Conventional Treatment of Vulvo-vaginal Candidiasis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Enumeration of Candida albicans in a vaginal sampling
研究概览
简要总结
This study aims to evaluate the effect of a specific strain of Saccharomyces cerevisiae on improving the effectiveness of conventional treatment of vulvo-vaginal candidiasis. This is a randomized, double-blind, placebo-controlled study.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Premenopausal female patient with a clinical diagnosed vulvo-vaginal candidiasis
- •Regularly menstruating women with normal gynaecological status
- •Patient must use a contraception method
- •Having given a written informed consent prior to selection
- •Covered by Health Insurance System and / or in compliance with the recommendations of National Law in force relating to biomedical research.
排除标准
- •Pregnancy or breast feeding.
- •Tumors in the genital tract or beast.
- •Hypersensitivity to the study product.
- •Uterine or vaginal bleeding of unknown origin.
- •Use of systemic or intravaginal antibiotic or antifungal agents in the previous 14 days.
- •Concomitant medication with antimycotics for other diagnoses.
- •Woman with known transmitted infections such as Neisseria gonorrhoea, Chlamydia trachomatis, Treponema pallidum, herpes simplex, Trichomonas vaginalis, human papilloma virus, HIV 1 or
- •Immunocompromised individuals.
- •Subjects not willing to stop taking probiotics in the form of dietary supplements or convenient goods
- •Subject who, in the judgment of the Investigator, is likely to be non-compliant or uncooperative during the study, or unable to cooperate because of a language problem, poor mental development.
- •Subject under administrative or legal supervision.
- •Subject who participate to a previous study within 3 months.
结局指标
主要结局
Enumeration of Candida albicans in a vaginal sampling
时间窗: up to 2 months
次要结局
未报告次要终点
研究者
研究点 (2)
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