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

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).

Study Overview

• Status: Recruiting
• Conditions: Skin Microbiome; Vaginal Microbiome; Saliva Microbiome
• Intervention / Treatment: Other: no intervention

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Sarah Lebeer, Professor; Phone Number: +32 3 265 32 85; Email: sarah.lebeer@uantwerpen.be
• Study Contact Backup: Name: Sarah Ahannach; Phone Number: +32 3 265 32 17; Email: sarah.ahannach@uantwerpen.be

Study Locations

• Belgium
  • Antwerp, Belgium, 2020
    • Recruiting
    • University of Antwerp and University Hospital Antwerp
    • Contact: Sarah Lebeer, Professor; Phone Number: +32 3 265 32 85; Email: sarah.lebeer@uantwerpen.be
    • Contact: Sarah Ahannach; Phone Number: +32 3 265 32 17; Email: sarah.ahannach@uantwerpen.be
    • Principal Investigator: Sarah Lebeer, Professor
    • Principal Investigator: Gilbert Donders, Professor
    • Sub-Investigator: Sarah Ahannach
    • Sub-Investigator: Eline Oerlemans, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

The study populations involves healthy women from 18 years and older.

Description

Inclusion Criteria:

• none

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy individuals	Other: no intervention; self-sampling

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Antwerp

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2020
• Primary Completion (Anticipated): July 1, 2025
• Study Completion (Anticipated): July 1, 2025

Study Registration Dates

• First Submitted: March 20, 2020
• First Submitted That Met QC Criteria: March 20, 2020
• First Posted (Actual): March 24, 2020

Study Record Updates

• Last Update Posted (Actual): January 27, 2021
• Last Update Submitted That Met QC Criteria: January 26, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Microbiota; Probiotics; vaginal microbiome; Metagenomic sequencing; skin microbiome; saliva microbiome; large-scale self-sampling cohort
• Other Study ID Numbers: B300201942076

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No