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

Recruiting

• Conditions: Vaginal Microbiome

• Registration Number: NCT06912126
• Lead Sponsor: University Hospital, Antwerp

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-03-20
• Study First Submitted QC: 2025-03-27
• Study First Posted: 2025-04-04
• Study Start: 2025-04-14
• Last Update Submitted: 2025-04-15
• Last Update Posted: 2025-04-16
• Primary Completion: 2026-03-01
• Study Completion: 2032-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Characterizing the origin and transmission of the vaginal microbiome	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.

Secondary Outcome Measures

Name	Time	Method
Identifying factors associated with the transmission and persistence of the vaginal microbiome	Up to six years	Questionnaire data and metagenomic data will be integrated to identify factors influencing the transmission and persistence of the vaginal microbiome at the strain level.
Characterizing the longitudinal stability of the vaginal microbiome	Up to six years	The longitudinal stability (i.e., persistence) of the vaginal microbiome will be characterized using metagenomic sequencing data from samples collected during Phase II). Specifically, bioinformatics tools will be used to evaluate the persistence of specific microbial strains within each participant's microbiome over time. Stability will be analyzed by comparing strain composition across the different time points. If necessary, strain-specific primers and polymerase chain reaction (PCR) will be used to confirm strain persistence.
Characterizing the vaginal microbiome at the functional level	Up to six years	Functional profiles will be annotated based on sequencing reads and compared between samples with and without the presence and persistence of shared strains using statistical analyses. Differences in metabolic pathways and microbial functions will be assessed to determine their impact on microbiome composition and stability.
Determining genetic associations with the colonization, persistence and transmission of the vaginal microbiome	Up to six years	If the participant agrees, human genetic data will be extracted from metagenomic sequences and analyzed using in-house and publicly available pipelines. The focus will be on identifying common genetic variations that may influence the colonization, transmission, and persistence of specific vaginal microbiome strains. Genes and mutations linked to serious diseases will not be analyzed.
Characterizing the determinants of the vaginal microbiome and metabolome	Up to six years	Metagenomic and metabolomic data will be integrated with questionnaire responses to investigate factors influencing microbial interactions and metabolite production. The analysis will determine whether metabolite production is influenced by (1) stable host factors (e.g., age, smoking status), (2) dynamic host factors (e.g., recent sexual activity, menstrual cycle phase), or (3) microbiome composition (e.g., community state type, eigentaxa abundances). All data will be securely stored with appropriate protections.

Trial Locations

Locations (1)

University of Antwerp; 🇧🇪 Antwerp, Belgium