Impact of the Use of Internal Menstrual Protections on Immunity and Vaginal Microbiota
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Determine the effect of the use of internal menstrual products on the composition of the vaginal microbiota.
研究概览
简要总结
The availability, effectiveness, and safety of menstrual protection represent a key public health issue. However, research on women's menstrual and sexual health remains extremely limited. Whether societal or pathological, many hypotheses are emerging regarding the effects of menstrual protection products, yet little attention has been given to the products themselves, their societal role, or their physiological and pathological consequences. Internal menstrual products, such as tampons and menstrual cups, are widely used but are subject to limited regulatory oversight, and few studies have investigated their long-term effects on vaginal health.
This study aims to investigate how different types of menstrual protection influence vaginal microbiota, immune responses, and the recurrence of gynecological conditions such as bacterial vaginosis, mycosis, or dysbiosis. Biological samples (vaginal, cervical, urinary, and blood) will be collected to analyze vaginal microbiota composition and local immunity. Participants will be divided into three groups based on their main type of menstrual protection: menstrual cup users, tampon users, and external pad users. The study will compare these groups to assess potential differences in vaginal health and immune response related to menstrual product use.
详细描述
The aim of this study is to investigate potential links between the type of menstrual protection used and variations in vaginal health, including microbial composition, immune responses, and exposure to environmental pollutants.
The project consists of two complementary components:
- Epidemiological Study: An online survey will be conducted with 1,500 to 1,800 participants, collecting detailed information on the usage habits of menstrual protection products (such as menstrual cups, tampons, and external pads), as well as self-reported symptoms and history of urogenital infections. This dataset will allow for large-scale correlation analyses between menstrual hygiene practices and women's health indicators.
- Clinical Study:
A total of approximately 300 women will be recruited and divided into three groups based on their primary menstrual protection method:
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 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Willingness to comply with all study procedures and availability for the duration of the study.
- •Female, aged 18 to 49 years.
- •In general good health, as determined by medical history.
- •Covered by the national health insurance system.
- •Willing to sign a written informed consent form.
- •Has already experienced menstruation prior to the start of the study.
- •No vaginal sexual intercourse within 72 hours before the study visit.
- •Has had at least 6 menstrual periods in the past 12 months.
排除标准
- •HIV infection.
- •Positive diagnosis for chlamydia or syphilis at screening or within 4 weeks prior to screening.
- •History of hormonal disorders or menstrual cycle irregularities.
- •Metrorrhagia.
- •Pregnancy or breastfeeding.
- •Family members or close relatives of the clinical or scientific team.
- •Treatment with any medication for chronic inflammatory disease or chronic conditions (e.g., cancer, arthritis, transplantation) within the past 12 months.
- •Participation in an ongoing clinical trial.
- •Receiving or having received antibiotic treatment within the 4 weeks prior to the study.
- •Refusal to be informed in case of detected abnormalities.
- •Indistinct use of both tampons and menstrual cups.
- •Never having had vaginal penetrative intercourse.
研究组 & 干预措施
Tampon-only user
This group includes participants who have been using single-use tampons as their main form of menstrual protection in the past six months.
干预措施: Samples collection (whole blood, urine, vaginal and cervical cells) (Other)
Cups-only user
This group includes participants who have used reusable menstrual cups as their main form of protection in the past six months.
干预措施: Samples collection (whole blood, urine, vaginal and cervical cells) (Other)
External-only user
This group includes participants who have not used any internal menstrual products in the past six months, relying instead on external protection such as sanitary pads.
干预措施: Samples collection (whole blood, urine, vaginal and cervical cells) (Other)
结局指标
主要结局
Determine the effect of the use of internal menstrual products on the composition of the vaginal microbiota.
时间窗: Samples will be stored at -80°C and metagenomics sequencing will be performed within 24 months after collection.
To investigate potential differences in microbiota between study groups, the investigators will perform metagenomics next-generation sequencing on vaginal swabs.
次要结局
- Comparison of the vaginal immune response of users and non-users of internal menstrual products(Samples for this purpose will be prepared for preservation immediately after collection. After preparation, they will be stored at -80°C and subsequently shipped for the analyses.)
- Effect of the type of internal menstrual protections on the presence of pollutants in urine.(Urine samples will be stored at -80°C and analysed within 24 months after collection.)
研究者
Samuel Alizon
Principal Investigator
Centre National de la Recherche Scientifique, France