Integrated Genetic and Functional Analysis of the Female Microbiome in a Flemish Cohort

NCT ID: NCT04319536

Last Updated: 2021-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-01

Study Completion Date

2025-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The aim of the project is to improve our knowledge on the stability and temporal dynamics of the Flemish female microbiome (vagina, skin and saliva) in relation to different lifestyle factors and environmental conditions and to establish certain individual and social risk factors that can influence the healthy microbiome. Therefore, microbial DNA from swabs will be isolated via commercially available DNA extraction kits, followed by Illumina MiSeq sequencing in order to identify the microbial species present in these samples. Special attention will go to microbial species that are overrepresented in the healthy populations as potential health promoting microbes (i.e. probiotics).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Vaginal Microbiome Skin Microbiome Saliva Microbiome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Healthy individuals

no intervention

Intervention Type OTHER

self-sampling

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

no intervention

self-sampling

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* none

Exclusion Criteria

* none
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Antwerp

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

[email protected]

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Antwerp and University Hospital Antwerp

Antwerp, , Belgium

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Belgium

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Sarah Lebeer, Professor

Role: CONTACT

+32 3 265 32 85

Sarah Ahannach

Role: CONTACT

+32 3 265 32 17

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Sarah Lebeer, Professor

Role: primary

+32 3 265 32 85

Sarah Ahannach

Role: backup

+32 3 265 32 17

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

B300201942076

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Acute Microbial Switch
NCT05764200 RECRUITING NA