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

NCT04894422 | Unknown

• 1 other identifier: B3002021000072
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Keywords

skin microbiome; 16S amplicon sequencing; face masks; upper airway microbiome; shotgun sequencing

Outcome Measures

Primary Outcomes (2)

• Change from baseline in microbiome composition of the skin and upper airways after wearing a face mask

  16S rRNA sequencing

  Start, 4 hours

• Optimalization of microbiome analysis of skin and upper airway samples

  16S rRNA sequencing, shotgun metagenomic sequencing

  Start

Study Arms (3)

No face mask

Volunteers who did not wear a face mask

Other: Observational intervention

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

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

Interventions

Observational intervention OTHER

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; No face mask; Surgical face mask

Eligibility Criteria

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

Study Population

Healthy, adult volunteers

You may qualify if:

• Adult age 18 at the start of the study

You may not qualify if:

• Pregnant women

Sponsors & Collaborators

• University Hospital, Antwerp: lead
• Universiteit Antwerpen: collaborator

Study Sites (1)

University of Antwerp and University Hospital Antwerp

Antwerp, 2020, Belgium

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Isolation of microbial DNA and/or RNA out of skin and upper airway swabs.

Study Officials

• Sarah Lebeer, Prof.

  Universiteit Antwerpen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Lebeer, Prof.

CONTACT

+3232653285; sarah.lebeer@uantwerpen.be

Veronique Verhoeven, Prof. Dr.

CONTACT

+3232652518; veronique.verhoeven@uantwerpen.be

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 11, 2021
• First Posted: May 20, 2021
• Study Start: March 15, 2021
• Primary Completion: December 31, 2021
• Study Completion: March 15, 2023
• Last Updated: May 20, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)