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

• Sponsor: University Hospital, Antwerp (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04319536
• Collaborator: (none)
• Enrollment: 1,000
• Location: 1
• Anticipated Duration (Months): 64
• Patients Per Site Per Month: 15.6

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Vaginal Microbiome; Skin Microbiome; Saliva Microbiome	Other: no intervention

Study Design

• Study Type: Observational
• Anticipated Enrollment: 1000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Integrated Genetic and Functional Analysis of the Female Microbiome in a Flemish Cohort
• Actual Study Start Date: Mar 1, 2020
• Anticipated Primary Completion Date: Jul 1, 2025
• Anticipated Study Completion Date: Jul 1, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• none

Exclusion Criteria:

• none

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Antwerp and University Hospital Antwerp	Antwerp		Belgium	2020

Sponsors and Collaborators

• University Hospital, Antwerp

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: [e-mail], Professor, Universiteit Antwerpen
• ClinicalTrials.gov Identifier: NCT04319536
• Other Study ID Numbers: B300201942076
• First Posted: Mar 24, 2020
• Last Update Posted: Jan 27, 2021
• Last Verified: Jan 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by [e-mail], Professor, Universiteit Antwerpen: Metagenomic sequencing; vaginal microbiome; skin microbiome; saliva microbiome; large-scale self-sampling cohort; Microbiota; Probiotics

Study Results

No Results Posted as of Jan 27, 2021