NCT06486519招募中不适用
Collection of Vaginal Microbiota From Healthy Women Subject to Vaginal and Urinary Infections (VAGINOTYPE)
Lallemand Health Solutions1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年5月14日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Composition of the vaginal microbiome
研究概览
简要总结
The aim of this study is to collect vaginal microbiota samples from healthy women who are subject to vaginal and urinary infections.
详细描述
The goal of this study is to collect vaginal swab samples in order to gain knowledge on vaginal microbial communities of healthy women who have had experiences with vaginal and urinary infections.
Eligible participants will be enrolled in the study for a total duration of 1 day, where they will provide consent, answer a questionnaire and collect the vaginal samples.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age between 18 and 60 years (limits included),
- •BMI between 18 and 30 kg/m² (limits included),
- •Good general and mental health within the opinion of the investigator: no clinically significant and relevant abnormalities of medical history or physical examination,
- •Able and willing to participate to the study by complying with the protocol procedures as evidenced by the dated and signed informed consent form,
- •Affiliated with a social security scheme,
- •Women who have had a vaginal or urinary infection in the last two years.
排除标准
- •Suffering from gastrointestinal acute or chronic disease or complication (e.g. celiac disease, gastroesophageal reflux disease, gastric or duodenal ulcer, Crohn's disease, hemorrhoids, irritable bowel syndrome) or frequent gastrointestinal disorders (e.g. diarrhea, nausea, vomiting, abdominal pain, constipation, hemorrhoids...)
- •Any infectious gastrointestinal complaint within 4 weeks before V1
- •Suffering from a metabolic disorder such as diabetes, thyroidal trouble, arterial hypertension or other metabolic disorder or any disease requiring a chronic treatment
- •Suffering from a severe chronic disease (e.g. cancer, HIV, renal failure, cardiac, hepatic or biliary disorders ongoing, chronic inflammatory digestive disease, arthritis or other chronic respiratory trouble, etc.) or disease found to be inconsistent with the conduct of the study by the investigator
- •Suffering from a pathology of the oral sphere (untreated caries, gingivitis, periodontitis, abscess, etc.) or having a positive result in an oral swab test for STIs (chlamydia, gonococcus, syphilis, herpes, etc.)
- •Women affected by a Sexually Transmitted Infection (STI) or Disease (STD) such as HPV (Human PapillomaVirus), Chlamydia infection, syphilis, gonorrhea, genital herpes
- •Having undergone a surgical procedure likely to disrupt the gut microbiome within the 6 months prior to the V1 visit, especially bariatric surgery
- •Coloscopy within 3 months prior to the visit
- •Women who gave birth within one year of the visit, women who are pregnant or intend to become pregnant during the study, women who are breastfeeding
- •E10.Previous or current antibiotic, antiviral, antifungal, proton pump inhibitor, or any treatment which may disrupt the microbiota in the 4 weeks prior to the V1 visit
- •E11.In the process of quitting smoking or having started smoking less than 6 months ago
- •E12.Taking part in another clinical trial or being in the exclusion period of a previous clinical trial
- •Having received, during the last 12 months, indemnities for clinical trial higher or equal to 6000 Euros
- •E14.Under legal protection (guardianship, wardship) or deprived from his rights following administrative or judicial decision
- •E15.Presenting a psychological or linguistic incapability to sign the informed consent
- •E16.Impossible to contact in case of emergency
结局指标
主要结局
Composition of the vaginal microbiome
时间窗: 1 day
Vaginal microbiota composition (α-diversity, β-diversity, and relative abundance at the genus and species level) at a single point in time via shotgun sequencing.
次要结局
未报告次要终点
研究者
研究点 (1)
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