NCT04989543已完成不适用
Study of the Composition and Bacterial Diversity of the Vaginal Microbiota in Healthy Versus Pathological Conditions (Bacterial Vaginosis) Using a Targeted Metagenomic Approach (RNA 16s)(CEBAM)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Larena SAS
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- Determine and compare the degree of vaginal bacterial alpha diversity in the absence (healthy population) or presence of bacterial vaginosis (pathological population).
研究概览
简要总结
It aims to determine and compare the degree of vaginal bacterial alpha diversity in the absence (healthy population) or presence of bacterial vaginosis (pathological population).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Woman aged between ≥ 18 and ≤ 45 years old,
- •In good general health (outside the gynaecological sphere), i.e. no chronic pathology and not taking medication at the time of inclusion and/or long-term,
- •Woman with a healthy or pathological vaginal flora according to Amsel's clinical diagnosis and Nugent's score :
- •Population with bacterial vaginosis (verification of at least the following 3 criteria + Nugent score):
- •Vaginal pH > 4.5
- •greyish, homogenous vaginal secretions adhering to the vaginal wall
- •characteristic vaginal odour of "rotten fish" after contact of the vaginal discharge with a few drops of 10% potash ("sniff test")
- •Presence of "Clue Cells" in the microscopic examination of fresh vaginal secretions. Clue cells are cells of the ectocervix lined with gram-negative bacilli.
- •Nugent Score ≥ 7
- •Healthy population (Verification of at least 3 following criteria + Nugent score) :
- •Absence of vaginal pH > 4.5
- •No greyish, homogenous vaginal secretions adhering to the vaginal wall
- •No characteristic vaginal odour of "rotten fish" after contact of the vaginal discharge with a few drops of 10% potash ("sniff test").
- •Absence of "Clue Cells" on microscopic examination of fresh vaginal secretions. Clue cells" are cells of the ectocervix lined with gram-negative bacilli.
- •Nugent Score ≤3
- •Able and willing to participate in the research by complying with the procedures of the protocol, especially regarding vaginal sampling,
- •Having given its free, informed and written consent.
排除标准
- •Patient during menstruation,
- •Patient who has had vaginal sex within 48 hours,
- •Patient with irregular menstrual cycles,
- •Patient undergoing preventive or curative treatment for vaginal infections,
- •Patients suffering from other diseases of the vagina (herpes, chlamydia, syphillis),
- •Patients undergoing antibiotic or antifungal treatments or taken less than 3 months ago,
- •Patient under probiotic or prebiotic complementation or taken less than a month ago,
- •Patient with systemic or immunodeficient disease,
- •Patient with an alcohol consumption of more than 2 glasses per day,
- •Pregnant or breastfeeding woman, or woman planning to become pregnant within the next 8 weeks, or woman in the post-partum period,
- •Patient unable to understand information related to the study (mental or linguistic disability),
- •Patient participating or having participated within the previous 3 months in another clinical trial, or in a period of exclusion from a clinical trial,
- •Patient not affiliated to a social security scheme.
结局指标
主要结局
Determine and compare the degree of vaginal bacterial alpha diversity in the absence (healthy population) or presence of bacterial vaginosis (pathological population).
时间窗: Day 0
The degree of vaginal bacterial alpha diversity in healthy and pathological conditions (bacterial vaginosis) will be evaluated by the Shannon index. It will be determined by the identification of the bacterial species (16s RNA analysis) present on a vaginal swab taken during the selection visit.
次要结局
- Determine and compare in healthy versus pathological conditions (bacterial vaginosis) : - vaginal specific richness in enterotypes, - The diversity of vaginal bacterial species by other indices, - The overall composition of the vaginal microbiota.(Day 0)
研究者
研究点 (2)
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