Status:
RECRUITING
The Maggie Project: Exploring the Origin and Heredity of the Vaginal Microbiome
Lead Sponsor:
University Hospital, Antwerp
Conditions:
Vaginal Microbiome
Eligibility:
All Genders
10+ years
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
April 14 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 31 2032
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT06912126
Start Date
April 14 2025
End Date
January 31 2032
Last Update
September 9 2025
Active Locations (1)
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1
University of Antwerp
Antwerp, Belgium, 2020