Studie Van de Vaginale Microbiota en Het Potentieel Van Een Vaginale Zalf Met Probiotica Bij Vaginale Candidose
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 主要终点
- Vaginal persistence of Candida species
研究概览
简要总结
This study evaluated the effect of a vaginal gel containing three live probiotic bacteria on vaginal Candida albicans infection in flemish patients (n=20). The therapeutic effects of the gel will be clinically evaluated (vaginal pH, microscopic and clinical scores). The effect on the vaginal microbiome will be evaluated through 16S ribosomal RNA amplicon sequencing via MiSeq Illumina and polymerase chain reaction (PCR) for Candida albicans.
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
- •Informed consent
- •willing to adhere to protocol
- •premenopausal
- •positive Candida microscopy and/or culture
- •at least two of the following vaginal symptoms: burning, itching, redness, fissure, discharge, vulvar edema, postcoital itching, lesions with partner
排除标准
- •vaginal use of any products 1 week or less before randomization
- •use of oral or local antimycotic treatment 1 week or less before randomization
- •unprotected sexual contact 24 hours preceding randomization
- •vaginal douching 24 hours preceding randomization
- •patient does not agree to participate in the study
研究组 & 干预措施
vulvovaginitis patients- lactobacillus gel
Daily use of vaginal gel containing lactobacilli by patients. Probiotic vaginal gel.
干预措施: Probiotic vaginal gel (Other)
结局指标
主要结局
Vaginal persistence of Candida species
时间窗: through study completion, estimated 1 year
The presence of Candida species in the collected samples will be analyzed by microscopy, culture (clinical lab) and after DNA extraction through quantitative PCR as molecular method. This will allow to estimate relative and absolute concentrations of the suspected infectious agent, and allow to evaluate if the infection cleared or not.
次要结局
- Clinical scores of patients(through study completion, estimated 1 year)
- Microbiome analysis(through study completion, estimated 1 year)
研究者
Ethisch Comité, UZA
Prof. Dr. Gilbert Donders, MD, PhD
University Hospital, Antwerp