Exploring the Vaginal Microbiome and Its Heredity

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

This study is trying to see how the vaginal microbiome is passed down and shared among women and their partners by collecting samples and information from them.

Quick facts

• Study type: Observational
• Enrollment: 500 (estimated)
• Ages: 10 Years and up
• Sex: All
• Sponsor: University Hospital, Antwerp (Academic / other)
• Locations: 1 site (Antwerp)
• Trial ID: NCT06912126 on ClinicalTrials.gov

What this trial studies

This observational study investigates the vaginal microbiome's origin and heredity through a citizen science approach. It aims to assemble a cohort of 100 networks, each consisting of a central female participant and 2 to 15 co-participants, totaling up to 500 individuals. Participants will provide vaginal or penis swabs, complete questionnaires, and central participants will also donate stool samples. The study seeks to understand shared microbial strains along the gut-vagina axis and within intimate microbiomes, focusing on the ecological dynamics of the vaginal microbiome.

Who should consider this trial

Good fit: Ideal candidates include pre-menopausal women aged 18 and over in good health, participating alongside their mothers and at least one additional co-participant.

Not a fit: Patients who are currently pregnant, breastfeeding, or have significant reproductive or gastrointestinal disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance understanding of the vaginal microbiome, leading to improved women's health and reproductive outcomes.

How similar studies have performed: While the specific approach of this study may be novel, other studies have explored aspects of the vaginal microbiome with varying degrees of success.

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) 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.

Exclusion Criteria of Central Participants:

* 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.

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.

Where this trial is running

Antwerp

• University of Antwerp — Antwerp, Belgium (Recruiting)

Study contacts

• Principal investigator: Sarah Lebeer, Professor — Universiteit Antwerpen
• Study coordinator: Veronique Verhoeven, Professor

Conditions Vaginal Microbiome; Vaginal microbiome; Microbiome transmission; Longitudinal stability; Networks