Microbiome Analysis of Skin and Airway Samples and Effect of Face Masks

May 19, 2021 updated by: Sarah Lebeer, University Hospital, Antwerp

Effect of Face Masks on the Microbial Communities of the Skin and Upper Airways and the Optimalisation of Microbiome Analysis

The goal of this study is to optimize two methods for microbiome analysis of skin and upper airway samples (16S amplicon sequencing and Shotgun sequencing). In addition, the researchers will investigate whether there is an effect of wearing a face mask on the microbial communities of the skin and upper airways. The volunteers will self-collect swabs of the skin and upper airways (nose and/or throat). Bacterial DNA and/or total RNA will be isolated and the microbial communities will be investigated with 16S amplicon sequencing and shotgun metagenomic sequencing.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
      • Antwerp, Belgium, 2020
        • Recruiting
        • University of Antwerp and University Hospital Antwerp
        • Contact:
        • Principal Investigator:
          • Sarah Lebeer, Professor
        • Contact:
        • Sub-Investigator:
          • Ilke De Boeck, Doctor
        • Sub-Investigator:
          • Eline Cauwenberghs, PhD student
        • Sub-Investigator:
          • Lize Delanghe, PhD student

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Healthy, adult volunteers

Description

Inclusion Criteria:

  • Adult age 18 at the start of the study

Exclusion Criteria:

  • Pregnant women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
No face mask
Volunteers who did not wear a face mask
Other: Observational intervention
Voluntarily (not) wearing a face mask (cotton or surgical) for 4 hours, following the government's guidelines during the COVID-19 pandemic.
Cotton face mask
Voluntarily wearing a cotton face mask for 4 hours, following the government's guidelines during the COVID-19 pandemic.
Other: Observational intervention
Voluntarily (not) wearing a face mask (cotton or surgical) for 4 hours, following the government's guidelines during the COVID-19 pandemic.
Surgical face mask
Voluntarily wearing a surgical face mask for 4 hours, following the government's guidelines during the COVID-19 pandemic.
Other: Observational intervention
Voluntarily (not) wearing a face mask (cotton or surgical) for 4 hours, following the government's guidelines during the COVID-19 pandemic.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in microbiome composition of the skin and upper airways after wearing a face mask
Time Frame: Start, 4 hours
16S rRNA sequencing
Start, 4 hours
Optimalization of microbiome analysis of skin and upper airway samples
Time Frame: Start
16S rRNA sequencing, shotgun metagenomic sequencing
Start

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Antwerp

Collaborators

Universiteit Antwerpen

Investigators

  • Principal Investigator: Sarah Lebeer, Prof., Universiteit Antwerpen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2021

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

March 15, 2023

Study Registration Dates

First Submitted

May 11, 2021

First Submitted That Met QC Criteria

May 19, 2021

First Posted (Actual)

May 20, 2021

Study Record Updates

Last Update Posted (Actual)

May 20, 2021

Last Update Submitted That Met QC Criteria

May 19, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • B3002021000072

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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