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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04894422
• Other study ID #: B3002021000072
• Status: Recruiting
• Start date: March 15, 2021
• Est. completion date: March 15, 2023

Study information

• Verified date: May 2021
• Source: University Hospital, Antwerp
• Contact: Sarah Lebeer, Prof.
• Phone: +3232653285
• Email: sarah.lebeer[@]uantwerpen.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 15, 2023
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult age 18 at the start of the study

Exclusion Criteria:

• Pregnant women

Related Conditions & MeSH terms

• Healthy

Intervention

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.

Locations

Country	Name	City	State
Belgium	University of Antwerp and University Hospital Antwerp	Antwerp

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Antwerp	Universiteit Antwerpen

Country where clinical trial is conducted

Belgium, 

Outcome

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