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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04319536
Acronym
Isala
Enrollment
1000
Registered
2020-03-24
Start date
2020-03-01
Completion date
2025-07-31
Last updated
2021-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Saliva Microbiome, Skin Microbiome, Vaginal Microbiome

Keywords

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

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).

Interventions

OTHERno intervention

self-sampling

Sponsors

University Hospital, Antwerp
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* none

Exclusion criteria

* none

Design outcomes

Primary

MeasureTime frameDescription
Differences in microbial communities colonizing the vagina, skin and saliva between healthy individuals measured with Illumina MiSequp to 5 yearsAfter 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).

Countries

Belgium

Contacts

Primary ContactSarah Lebeer, Professor
sarah.lebeer@uantwerpen.be+32 3 265 32 85
Backup ContactSarah Ahannach
sarah.ahannach@uantwerpen.be+32 3 265 32 17

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026