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临床试验/NCT06912126
NCT06912126招募中不适用

The Maggie Project: Exploring the Origin and Heredity of the Vaginal Microbiome

University Hospital, Antwerp1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2025年4月14日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
500
试验地点
1
主要终点
Characterizing the origin and transmission of the vaginal microbiome

研究概览

简要总结

The vaginal microbiome plays a crucial role in women's health and reproduction, impacting not only women but also their partners and children. However, its ecology and primary colonizers are not well understood. This study aims to explore the origin and heredity of the vaginal microbiome using a citizen science approach. The researchers will assemble a cohort of 100 networks, each with a central participant and 2 to 15 co-participants, totaling up to 500 participants. Participants will provide vaginal or penis swabs, complete questionnaires, and central participants will also donate stool samples. Girls under 18 may participate as co-participants if their mothers are enrolled, with first-void urine samples as an alternative method. Male partners can be included if they have intimate contact with central participants, but male family members and friends will not be part of the study. In the first phase, shared microbial strains along the gut-vagina axis and within the intimate microbiomes of participants from the same and different networks will be assessed. Transmission pathways will also be examined. Additionally, the metabolic environment in the vagina will be characterized. In the second phase, central participants will self-collect weekly vaginal swabs at three time points per year over five years. This phase will provide insights into the persistence and stability of the vaginal microbiome and the vaginal metabolic environment. If consent is given, genetic data from metagenomic sequencing will be analyzed to focus on variations related to the colonization, transmission, and persistence of microbial strains. This study will offer valuable insights into the origins, transmission, and long-term dynamics of the vaginal microbiome.

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
10 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Characterizing the origin and transmission of the vaginal microbiome

时间窗: Up to one year

After metagenomic shotgun sequencing, bioinformatic tools will be used to analyze taxonomic and functional data. Vaginal and stool metagenomes from central participants will be compared at the species and strain levels, complemented by whole-genome sequencing of bacterial isolates to identify shared strains between the gut and vaginal microbiomes in the central participants. In addition, microbiome profiles from vaginal, penile, and urine samples will also be compared between central participants and their co-participants within networks. This analysis will then be expanded to examine strain transmission across the entire cohort. Statistical analyses will assess strain similarities within networks, across the cohort, and among all participants.

次要结局

  • Identifying factors associated with the transmission and persistence of the vaginal microbiome(Up to six years)
  • Characterizing the longitudinal stability of the vaginal microbiome(Up to six years)
  • Characterizing the vaginal microbiome at the functional level(Up to six years)
  • Determining genetic associations with the colonization, persistence and transmission of the vaginal microbiome(Up to six years)
  • Characterizing the determinants of the vaginal microbiome and metabolome(Up to six years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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