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临床试验/NCT06519799
NCT06519799招募中不适用

Integrated Genetic and Functional Analysis of the Influence of Menstrual Hygiene Products on Female Health

University Hospital, Antwerp2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
2
主要终点
Beta diversity of the vaginal microbiome

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
None

盲法说明

As the intervention is the use of a menstrual product, no masking is possible.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • contraception: combination pill with stop week or no hormonal contraception
  • premenopausal
  • Dutch-speaking living in Belgium
  • regular menstrual cycle (if no hormonal contraception)

排除标准

  • Pregnancy

结局指标

主要结局

Beta diversity of the vaginal microbiome

时间窗: 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.

次要结局

  • 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.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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