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

Vaginal Microbiome Clinical Trial

— Isala  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04319536
• Other study ID #: B300201942076
• Status: Recruiting
• Start date: March 1, 2020
• Est. completion date: July 2025

Study information

• Verified date: January 2021
• Source: University Hospital, Antwerp
• Contact: Sarah Lebeer, Professor
• Phone: +32 3 265 32 85
• Email: sarah.lebeer[@]uantwerpen.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• none

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Saliva Microbiome
• Skin Microbiome
• Vaginal Microbiome

Intervention

Other:
• no intervention
self-sampling

Locations

Country	Name	City	State
Belgium	University of Antwerp and University Hospital Antwerp	Antwerp

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Antwerp

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences in microbial communities colonizing the vagina, skin and saliva between healthy individuals measured with Illumina MiSeq	After metagenomic shotgun and amplicon sequencing with the Illumina MiSeq, bio-informatic tools will be used to analyse taxonomic and functional data. The investigators will specifically screen for health-promoting and pathogenic taxa that can be associated with specific environmental conditions and lifestyle factors. Additionally, the investigators will pay attention to the dominant members of the vaginal bacterial community (i.e. beneficial microbes such as lactic acid bacteria).	up to 5 years