Vaginal MicrobiomeMaggieNCT06912126
The Maggie Project: Exploring the Origin and Heredity of the Vaginal Microbiome
An observational study of Vaginal Microbiome, run by University Hospital, Antwerp at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vaginal Microbiome
- How many people
- 500 participants
- Where
- 1 siteBelgium
- Study dates
- 14 Apr 2025to 31 Jan 2032
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Central participants and their co-participants must live in Belgium.
Who may be able to join
- 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;
- Living in Belgium;
- Sufficient knowledge of the Dutch language;
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- Consent form signed;
- Participating alongside her mother and at least one additional co-participant in the study.
- Closely related to or interacting with the central participant of the network at least during the last six months or more before the study, e.g. her mother, aunts, female cousins, sisters, daughters, housemates, partners or close friends;
- Aged 18 or over at the time of enrollment; OR 10 or over if the co-participant's mother is also participating in the study;
- Sex: Female; OR male aged 18 and over who is the partner or one of the partners (in case of polygamous relationships) of the central participant;
- Self-reported good health (including the absence of general infection);
- Sufficient knowledge of the Dutch language;
- Consent form signed.
Who cannot join
- 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;
- Use of oral/vaginal pre-, pro-, post- and/or synbiotics in the 2 weeks before the beginning of the study;
- Vaginal showering during the study;
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- Participation in an intervention study.
- Use of oral/vaginal antibiotics/antifungals in the 2 months before the study;
- Parallel participation in an intervention study;
- Vaginal showering during the study;
- Clinically significant abnormalities of the reproductive organs or any other medical condition that, in the opinion of the principal investigator, warrants exclusion from the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
University of Antwerp
Antwerp, 2020
Veronique Verhoeven, Professor, +3232652518, veronique.verhoeven@uantwerpen.be
Sarah Lebeer, Professor, +3232653285, sarah.lebeer@uantwerpen.be
About this study
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.
- Conditions
- Vaginal Microbiome
- Keywords
- Vaginal microbiome, Microbiome transmission, Longitudinal stability, Networks
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Central participants | Central participants will be the primary members of each network, with their genetically and socially connected contacts integrated into their networks. These participants will be followed for five years during the phase II of the project. | |
| Co-participants | The group of co-participants in this study consists of individuals who are closely connected to the central participant either genetically or socially. Genetically connected co-participants may include family members such as mothers, daughters, sisters, and potentially other relatives. Socially connected co-participants could include individuals with whom the central participant shares a close relationship, such as partners, close friends, and roommates. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to one year
Secondary outcomes (5)
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.
Measured: Up to six years
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.
Measured: Up to six years
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.
Measured: Up to six years
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.
Measured: Up to six years
Characterizing the determinants of the vaginal microbiome and metabolome
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.
Measured: Up to six years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start14 Apr 2025
- Primary completion1 Mar 2026 (estimated)
- Study completion31 Jan 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal MicrobiomeStudies of the same condition, open and under way.
- More trials run by University Hospital, AntwerpThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarah Lebeer, Professor, Principal investigator, Universiteit Antwerpen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06912126
- Sponsor's protocol ID
- B3002025000011
- Acronym
- Maggie
- Status last verified
- Feb 2025
- First submitted
- 20 Mar 2025
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Maggie Project: Exploring the Origin and Heredity of the Vaginal Microbiome
- ClinicalTrials.gov ID
- NCT06912126
- Acronym / sponsor ID
- Maggie / B3002025000011
- Conditions
- Vaginal Microbiome
- Keywords
- Vaginal microbiome, Microbiome transmission, Longitudinal stability, Networks
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Study start
- 14 Apr 2025 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 31 Jan 2032 (estimated)
- First posted
- 4 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Central participants | – | –Central participants will be the primary members of each network, with their genetically and socially connected contacts integrated into their networks. These participants will be followed for five years during the phase II of the project. |
| Co-participants | – | –The group of co-participants in this study consists of individuals who are closely connected to the central participant either genetically or socially. Genetically connected co-participants may include family members such as mothers, daughters, sisters, and potentially other relatives. Socially connected co-participants could include individuals with whom the central participant shares a close relationship, such as partners, close friends, and roommates. |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Central participants and their co-participants must live in Belgium.
Key inclusion criteria (14 listed)
- 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;
- Living in Belgium;
Key exclusion criteria (11 listed)
- 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;
- Use of oral/vaginal pre-, pro-, post- and/or synbiotics in the 2 weeks before the beginning of the study;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Characterizing the origin and transmission of the vaginal microbiome
Time frame: 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.
5 secondary outcomes
Characterizing the longitudinal stability of the vaginal microbiome
Time frame: Up to six years
Identifying factors associated with the transmission and persistence of the vaginal microbiome
Time frame: Up to six years
Characterizing the vaginal microbiome at the functional level
Time frame: Up to six years
Determining genetic associations with the colonization, persistence and transmission of the vaginal microbiome
Time frame: Up to six years
Characterizing the determinants of the vaginal microbiome and metabolome
Time frame: Up to six years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sarah Lebeer, Professor principal investigator
Universiteit Antwerpen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vaginal Microbiome, run by University Hospital, Antwerp at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Veronique Verhoeven, Professor (+3232652518, veronique.verhoeven@uantwerpen.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterizing the origin and transmission of the vaginal microbiome (time frame: Up to one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.