Integrated Genetic and Functional Analysis of the Influence of Menstrual Hygiene Products on Female Health
NCT Number: NCT06519799
Acronym: Luna
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Vaginal Disease|Menstrual Discomfort
Interventions: OTHER: Menstrual hygiene products
Sponsor: University Hospital, Antwerp
Collaborators: Universiteit Antwerpen|Research Foundation Flanders
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-08-01
Completion Date: 2025-10-31
Locations: University of Antwerp, Antwerp, 2020, Belgium

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.

Primary Outcome Measures: Beta diversity of the vaginal microbiome, 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., Each month for 3 samplepoints until study completion, an average of 6 months
Secondary Outcome Measures: relative abundance of eigentaxa, The relative abundance of some eigentaxa such as Lactobacillus crispatus will be looked at, as this is known to be associated with some menstrual products. The relative abundance at each samplepoint will be evaluated at the end of the study, comparison will be made between the different menstrual hygiene products., Each month for 3 samplepoints until study completion, an average of 6 months|comfort and ease of use, the participants will answer evaluate the comfort and ease of use of each product, during the survey at the timepoint after each menstruation for each product., Periodically, after menstruation once a month.|alfa diversity of the vaginal microbiome, this measure describes the taxonomic diversity within a sample. The alfa diversity within a participant over all products will be calculated as a measure of stability. 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., 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, these measures describe the taxonomic diversity. Comparison will be made between different menstrual hygiene products., Each month for 3 samplepoints until study completion, an average of 6 months