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

• Sponsor: University Hospital, Antwerp (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04894422
• Collaborator: Universiteit Antwerpen (Other)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 24
• Patients Per Site Per Month: 4.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Other: Observational intervention

Study Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Effect of Face Masks on the Microbial Communities of the Skin and Upper Airways and the Optimalisation of Microbiome Analysis
• Actual Study Start Date: Mar 15, 2021
• Anticipated Primary Completion Date: Dec 31, 2021
• Anticipated Study Completion Date: Mar 15, 2023

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. Change from baseline in microbiome composition of the skin and upper airways after wearing a face mask [Start, 4 hours]

   16S rRNA sequencing

2. Optimalization of microbiome analysis of skin and upper airway samples [Start]

   16S rRNA sequencing, shotgun metagenomic sequencing

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Adult age 18 at the start of the study

Exclusion Criteria:

• Pregnant women

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
• Universiteit Antwerpen

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sarah Lebeer, Principal Investigator, University Hospital, Antwerp
• ClinicalTrials.gov Identifier: NCT04894422
• Other Study ID Numbers: B3002021000072
• First Posted: May 20, 2021
• Last Update Posted: May 20, 2021
• Last Verified: May 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Sarah Lebeer, Principal Investigator, University Hospital, Antwerp: skin microbiome; 16S amplicon sequencing; face masks; upper airway microbiome; shotgun sequencing

Study Results

No Results Posted as of May 20, 2021