Exploring the Vaginal Microbiome and Its Heredity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University of Antwerp
  Antwerp, Belgium Recruiting

Study contacts

• Principal investigator: Sarah Lebeer, Professor — Universiteit Antwerpen
• Study coordinator: Veronique Verhoeven, Professor
• Email: veronique.verhoeven@uantwerpen.be
• Phone: +3232652518

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Impact of vaginal bacteria on pregnancy success after embryo transfer

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• Using synbiotics to reduce the risk of preterm birth

  This study is testing if taking synbiotics can help women at high risk for preterm birth have healthier pregnancies by improving their vaginal microbiome.

  Recruiting at 9 sites Ziekenhuis Oost-Limburg · Edegem, Antwerpen and 8 other locations · NCT05966649

• Exploring the Uterine Microbiome in Women with Recurrent Pregnancy Loss

  This study looks at the bacteria in the uterus and vagina of women who have had multiple pregnancy losses to see how it compares to those who have had healthy pregnancies.

  Recruiting at 2 sites Mỹ Đức Hospital · Ho Chi Minh City, Ho Chi Minh City and 1 other locations · NCT05510622

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.