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

Launched by UNIVERSITY HOSPITAL, ANTWERP · Mar 27, 2025

Keywords

ClinConnect Summary

The Maggie Project is a clinical trial that aims to better understand the vaginal microbiome, which is the collection of bacteria and other microorganisms in the vagina that play an important role in women’s health. The study will involve a total of 500 participants, including a central participant (a woman) and her close family and friends, who will provide samples such as vaginal or penis swabs and, for central participants, stool samples. By studying these samples over five years, the researchers hope to learn how the vaginal microbiome develops, changes, and what factors might affect it.

To participate as a central participant, you need to be a healthy, pre-menopausal woman aged 18 or older, able to speak Dutch, and not currently pregnant or breastfeeding. If you are a close family member or partner of a central participant, you might also be eligible to join as a co-participant. Throughout the study, participants will collect samples at different times and complete questionnaires about their health. This research could provide valuable insights into how the vaginal microbiome influences not just women's health, but also the health of their partners and children.

Gender

ALL

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.