Actively Recruiting
The Maggie Project: Exploring the Origin and Heredity of the Vaginal Microbiome
Led by University Hospital, Antwerp · Updated on 2025-09-09
500
Participants Needed
1
Research Sites
354 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
The Maggie Project: Exploring the Origin and Heredity of the Vaginal Microbiome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 and over at the time of enrollment (central participants)
- Female sex (central participants)
- Pre-menopausal (central participants)
- Self-reported good health without general infection at study start (central participants)
- Living in Belgium (central participants)
- Sufficient knowledge of the Dutch language (central participants)
- Signed consent form (central participants)
- Participating alongside her mother and at least one additional co-participant (central participants)
- Closely related to or interacting with the central participant for at least six months before the study (co-participants)
- Aged 18 or over at enrollment, or 10 or over if the co-participant's mother is also participating (co-participants)
- Female sex, or male aged 18 or over who is a partner of the central participant (co-participants)
- Self-reported good health without general infection (co-participants)
- Sufficient knowledge of the Dutch language (co-participants)
- Signed consent form (co-participants)
You will not qualify if you...
- Current or planned pregnancy at the beginning of the study (central participants)
- Current cancer diagnosis or immunosuppressive therapy within 6 months before the study (central participants)
- Clinically significant abnormalities of reproductive organs or other medical conditions deemed exclusionary by the principal investigator (central participants)
- Use of oral or vaginal antibiotics or antifungals within 2 months before study start (central and co-participants)
- Use of oral or vaginal pre-, pro-, post-, or synbiotics within 2 weeks before study start (central participants)
- Vaginal showering during the study (central and co-participants)
- Participation in another intervention study (central and co-participants)
- Clinically significant abnormalities of reproductive organs or medical conditions warranting exclusion as judged by the principal investigator (co-participants)
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Antwerp
Antwerp, Belgium, 2020
Actively Recruiting
Research Team
V
Veronique Verhoeven, Professor
CONTACT
S
Sarah Lebeer, Professor
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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