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

NCT06912126 | Recruiting DMC

• 1 other identifier: B3002025000011
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Vaginal Microbiome

Keywords

Vaginal microbiome; Microbiome transmission; Longitudinal stability; Networks

Outcome Measures

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.

  Up to one year

Secondary Outcomes (5)

• Characterizing the longitudinal stability of the vaginal microbiome

  Up to six years

• Identifying factors associated with the transmission and persistence 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 10 Years+
• Gender Eligibility Details: Central participants and co-participants will primarily be female. Male partners may be included if they have intimate contact with central participants, but male family members and friends will not be part of the study.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Central participants and their co-participants must live in Belgium.

You may qualify if:

• 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;
• Consent form signed;
• Participating alongside her mother and at least one additional co-participant in the study.

You may not qualify if:

• 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;
• Participation in an intervention 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.
• Use of oral/vaginal antibiotics/antifungals in the 2 months before the study;
• Parallel participation in an intervention study;

Sponsors & Collaborators

• University Hospital, Antwerp: lead

Study Sites (1)

University of Antwerp

Antwerp, 2020, Belgium

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Vagina/penis swabs (and/or urine samples, if applicable) and stool samples.

Study Officials

• Sarah Lebeer, Professor

  Universiteit Antwerpen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Veronique Verhoeven, Professor

CONTACT

+3232652518; veronique.verhoeven@uantwerpen.be

Sarah Lebeer, Professor

CONTACT

+3232653285; sarah.lebeer@uantwerpen.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2025
• First Posted: April 4, 2025
• Study Start: April 14, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): January 31, 2032
• Last Updated: September 9, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)