The Maggie Project: Exploring the Origin and Heredity of the Vaginal Microbiome
ConditionVaginal Microbiome
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age10+
SponsorUniversity Hospital, Antwerp
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Adults aged 18 and over at the time of enrollment;
Sex: Female;
Pre-menopausal;
Self-reported good health (including the absence of general infection) at the beginning of the study;
Disqualifiers
Current pregnancy or planned pregnancy at the beginning of the study;
Current diagnosis of cancer and/or immunosuppressive therapy in the 6 months before the study;
Clinically significant abnormalities of the reproductive organs or any other medical condition at the discretion of the principal investigator;
Use of oral/vaginal antibiotics/antifungals in the 2 months before the beginning of the study;
Trial population
Central participants and their co-participants must live in Belgium.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
500 Participants
are grouped into 2 trial groupsGroup A: Central participants
Group B: Co-participants
Trial outcomes
Primary outcomes
1
Characterizing the origin and transmission of the vaginal microbiome
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.
Time frame
Up to one yearSecondary outcomes
1
Characterizing the longitudinal stability of the vaginal microbiome
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.
Time frame
Up to six years2
Identifying factors associated with the transmission and persistence of the vaginal microbiome
Questionnaire data and metagenomic data will be integrated to identify factors influencing the transmission and persistence of the vaginal microbiome at the strain level.
Time frame
Up to six years3
Characterizing the vaginal microbiome at the functional level
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.
Time frame
Up to six years4
Determining genetic associations with the colonization, persistence and transmission of the vaginal microbiome
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.
Time frame
Up to six yearsSponsors and contacts
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Source ClinicalTrials.gov