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

Recruiting

• Conditions: Vaginal Microbiome; Skin Microbiome; Saliva Microbiome
• Interventions: Other: no intervention

• Registration Number: NCT04319536
• Lead Sponsor: University Hospital, Antwerp

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-01
• Study First Submitted: 2020-03-20
• Study First Submitted QC: 2020-03-20
• Study First Posted: 2020-03-24
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-26
• Last Update Posted: 2021-01-27
• Primary Completion: 2025-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 1000

Inclusion Criteria

• none

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy individuals	no intervention	-

Primary Outcome Measures

Name	Time	Method
Differences in microbial communities colonizing the vagina, skin and saliva between healthy individuals measured with Illumina MiSeq	up to 5 years	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).

Trial Locations

Locations (1)

University of Antwerp and University Hospital Antwerp; 🇧🇪 Antwerp, Belgium