Impact of Internal Menstrual Protections on Immunity and Vaginal Microbiota

Официальное название

Impact of the Use of Internal Menstrual Protections on Immunity and Vaginal Microbiota

Обзор

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.

Подробное описание

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:

Group 1: Menstrual cup users Group 2: Tampon users Group 3: External sanitary pad users

All clinical participants will undergo a gynecological examination and provide vaginal, cervical, urinary, and blood samples. These biological samples will be used for in-depth analysis across three main areas:

* Microbiology: studying the vaginal microbiota composition and identifying infectious or dysbiotic profiles. * Immunology: assessing local immune responses, including cytokine levels and antibody titers. * Toxicology: measuring exposure to potential environmental pollutants through menstrual product use.

Sequencing, immune profiling, pollutant quantification, and cytobacteriological screening will be conducted to evaluate potential differences between groups. These analyses aim to provide a better understanding of how menstrual protection methods may influence vaginal ecosystem balance, immune activity, and overall urogenital health.

Вмешательства

• Другое Samples collection (whole blood, urine, vaginal and cervical cells)
  During the clinical visit, samples will be collected from participants, including blood, urine, and vaginal and cervical cells. These samples will be used for a range of analyses, including determination of the vaginal microbiota composition and sequencing, cytokine profiling, and assessment of local immunity through flow cytometry using CyTOF technology. Urine samples will be analyzed for pollutants such as phthalates and bisphenol, while blood samples will be used for blood cell counts.

Первичные конечные точки

• Determine the effect of the use of internal menstrual products on the composition of the vaginal microbiota. [Срок оценки: Samples will be stored at -80°C and metagenomics sequencing will be performed within 24 months after collection.]

Вторичные конечные точки (2)

• Comparison of the vaginal immune response of users and non-users of internal menstrual products [Срок оценки: 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. [Срок оценки: Urine samples will be stored at -80°C and analysed within 24 months after collection.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Франция · 1 центр

• Institut Alfred Fournier — Paris

Публикации

• Tessandier N, Uysal IB, Elie B, Selinger C, Bernat C, Boue V, Grasset S, Groc S, Rahmoun M, Reyne B, Bender N, Bonneau M, Graf C, Tribout V, Foulongne V, Ravel J, Waterboer T, Hirtz C, Bravo IG, Reynes J, Segondy M, Murall CL, Boulle N, Kamiya T, Alizon S. Does exposure to different menstrual products affect the vaginal environment? Mol Ecol. 2023 May;32(10):2592-2601. doi: 10.1111/mec.16678. Epub PMID 36057782

Идентификаторы

NCT: NCT07199998 · 2024-A00597-40

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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