Clinical trial NCT06912126: The Maggie Project: Exploring the Origin and Heredity of the Vaginal Microbiome
Official title: The Maggie Project: Exploring the Origin and Heredity of the Vaginal Microbiome
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Vaginal Microbiome
Keywords: Vaginal microbiome
Microbiome transmission
Longitudinal stability
Networks
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
First posted: 2025-04-04
Enrollment: 500
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Central participants and their co-participants must live in Belgium.

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.


Eligibility criteria: Inclusion Criteria of Central Participants:

* Adults aged 18 and over at the time of enrollment;
* Sex: Female;
* Pre-menopausal;
* Self-reported good health (including the absence of general infection);
* Absence of reproductive disorders (e.g. endometriosis, polycystic ovary syndrome), vaginal infections and symptoms diagnosed by a medical professional;
* Absence of gastrointestinal disorders, infections and symptoms diagnosed by a medical professional;
* Sufficient knowledge of the Dutch language;
* Consent form signed;
* Participating alongside her mother and at least one additional co-participant in the study.

Exclusion Criteria of Central Participants:

* Current pregnancy or planned pregnancy at the beginning and during of the study;
* Breastfeeding at the start and during 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 and during the study;
* Use of oral/vaginal pre- and/or probiotics in the 2 weeks before the study and during the study;
* Vaginal showering during the study;
* Participation in an intervention study.

Inclusion Criteria of Co-participants:

* 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.

Exclusion Criteria of Co-participants:

* 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.

Primary outcomes:
measure: Characterizing the origin and transmission of the vaginal microbiome
timeFrame: Up to one year
Secondary outcomes:
measure: Characterizing the longitudinal stability of the vaginal microbiome
timeFrame: Up to six years
measure: Identifying factors associated with the transmission and persistence of the vaginal microbiome
timeFrame: Up to six years
measure: Characterizing the vaginal microbiome at the functional level
timeFrame: Up to six years
measure: Determining genetic associations with the colonization, persistence and transmission of the vaginal microbiome
timeFrame: Up to six years
measure: Characterizing the determinants of the vaginal microbiome and metabolome
timeFrame: Up to six years
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: University of Antwerp
Study officials:
affiliation: Universiteit Antwerpen
name: Sarah Lebeer, Professor
role: PRINCIPAL_INVESTIGATOR
References: