Prevention of Recurrent Vulvovaginal Candidiasis With Lactibiane Candisis 5M®
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- PiLeJe
- 入组人数
- 134
- 试验地点
- 2
- 主要终点
- The primary objective of this study was to investigate if Lactibiane candisis 5M supplementation could lengthen the time to relapse after initial local cure
研究概览
简要总结
Vulvovaginal candidiasis (VVC) is a common infection among women that is associated with considerable morbidity and health-care cost. 75% of women will suffer of Candida infection for at least one time in their life. 20% of women who suffer from VVC will have ≥ 4 episodes of VVC during the one year prior to the survey. 80% of these VVC are caused by Candida albicans. Current treatments, based on imidazoles, face many failures or recurrences. The type of probiotic Lactobacillus may participate in the prevention of recurrent vulvo-vaginitis in reducing the proliferation of intestinal Candida albicans, its adherence to the vaginal walls, the potentiation of its propagation. The primary objective of this study was to investigate if our supplementary treatment could improve the initial cure rate after vaginal econazole therapy.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18-65 years
- •suffering from 4 or more episodes of VVC during the 1 year prior to the survey
- •all participants must be symptomatic with a microbiological proof of infection with candida albicans
排除标准
- •Pregnancy, lactation being
- •HIV infection, chemotherapy or illness serious enough to induce an immune deficiency. A diabetic patient will not be systematically excluded;
- •Vulvo-vaginitis and / or cervicitis specific, defined in a bacteriological examination by the presence of herpes virus, gonorrhea or chlamydia;
- •Bacterial Vaginosis or Trichomonas;
- •Use of vaginal probiotics in the months before inclusion;
- •Cure of probiotics in the months preceding the inclusion;
- •Contraindication to Gynopévaryl LP
结局指标
主要结局
The primary objective of this study was to investigate if Lactibiane candisis 5M supplementation could lengthen the time to relapse after initial local cure
时间窗: 9 months
次要结局
- The secondary objective of this study is to compare the number of recurrence in the lactibiane candisis 5M group versus placebo.(2, 3, 6 and 9 months)