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

NCT04319536 | Unknown

• 1 other identifier: B300201942076
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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).

Conditions

Vaginal Microbiome; Skin Microbiome; Saliva Microbiome

Keywords

Metagenomic sequencing; vaginal microbiome; skin microbiome; saliva microbiome; large-scale self-sampling cohort; Microbiota; Probiotics

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Healthy individuals

Other: no intervention

Interventions

no intervention OTHER

self-sampling

Healthy individuals

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• none

You may not qualify if:

• none

Sponsors & Collaborators

• University Hospital, Antwerp: lead

Study Sites (1)

University of Antwerp and University Hospital Antwerp

Antwerp, 2020, Belgium

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Microbial DNA will be analysed from swabs

Central Study Contacts

Sarah Lebeer, Professor

CONTACT

+32 3 265 32 85; sarah.lebeer@uantwerpen.be

Sarah Ahannach

CONTACT

+32 3 265 32 17; sarah.ahannach@uantwerpen.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 20, 2020
• First Posted: March 24, 2020
• Study Start: March 1, 2020
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: January 27, 2021

Record last verified: 2021-01

Locations

BE (1)