Integrated Genetic and Functional Analysis of the Influence of Menstrual Hygiene Products on Female Health
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Vaginal Disease
- Sponsor
- University Hospital, Antwerp
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Beta diversity of the vaginal microbiome
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
Women's reproductive health has attracted increasing attention in recent years, including in the field of microbiology. Vaginal infections, such as vulvovaginal candidiasis, bacterial vaginosis and aerobic vaginitis, are common and a huge burden on our society. The vaginal microbiome is important in the prevention of these infections, in fertility and for healthy pregnancies. The composition, and therefore the 'health' of the vaginal microbiome, is influenced by many internal and external factors, including intimate health. However, it is not yet known how intimate health, and specifically the use of menstrual hygiene products, affects the microbiome and women's intimate comfort and health. In this study, the researchers aim to understand the influence of 5 menstrual hygiene products (tampon, menstrual cup, menstrual pad and 2 types of menstrual underwear) on women's intimate health (n = 100). First, this will be evaluated at the microbiome level, focusing on the female intimate microbiome, consisting of the skin in the groin, vulvar and vaginal microbiome. These sites are all closely linked and are affected in vaginal infections or by contact with menstrual hygiene products. Second, in addition to the direct impact on the microbiome, the impact on the participant's immune system will be evaluated, as some well-known menstrual hygiene products can cause irritation and inflammation. As a third goal, participants will assess the comfort and usability of each menstrual hygiene product and provide data on their lifestyle and other factors that may influence our results. The main goal is to investigate and define the impact of menstrual hygiene products on women's intimate health so that women can make an informed choice. In a first phase participants (n = 1500) will fill in a survey containing questions on general health, lifestyle and menstrual health. Based on these responses a selection of 100 participants will be made by the researchers to participate in the intervention trial.
Investigators
Eligibility Criteria
Inclusion Criteria
- •contraception: combination pill with stop week or no hormonal contraception
- •premenopausal
- •Dutch-speaking living in Belgium
- •regular menstrual cycle (if no hormonal contraception)
Exclusion Criteria
- •Pregnancy
Outcomes
Primary Outcomes
Beta diversity of the vaginal microbiome
Time Frame: Each month for 3 samplepoints until study completion, an average of 6 months
This measure describes the taxonomic diversity between samples, a higher diversity is associated with a less healthy vaginal microbiome. Beta diversity within a participant over all products will be calculated as a stability measure. This will be defined for each participant comparing the baseline samples (right before menstruation) to the sample during and after menstruation. Comparison will be made between different menstrual hygiene products.
Secondary Outcomes
- alfa diversity of the vaginal microbiome(Each month for 3 samplepoints until study completion, an average of 6 months)
- both alfa and beta diversity of the vulvar and groin skin microbiome(Each month for 3 samplepoints until study completion, an average of 6 months)
- relative abundance of eigentaxa(Each month for 3 samplepoints until study completion, an average of 6 months)
- comfort and ease of use(Periodically, after menstruation once a month.)