HealthyNCT04894422
Microbiome Analysis of Skin and Airway Samples and Effect of Face Masks
An observational study of Healthy, run by University Hospital, Antwerp at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Observational intervention
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Mar 2021to 15 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy, adult volunteers
Who may be able to join
- Adult age 18 at the start of the study
Who cannot join
- Pregnant women
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
University of Antwerp and University Hospital Antwerp
Antwerp, 2020
Sarah Lebeer, Professor, +32 3 265 32 85, sarah.lebeer@uantwerpen.be
Lize Delanghe, +32 3 265 32 17, lize.delanghe@uantwerpen.be
About this study
Official title: 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.
- Conditions
- Healthy
- Being tested
- Observational intervention
- Keywords
- skin microbiome, 16S amplicon sequencing, face masks, upper airway microbiome, shotgun sequencing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational interventionOther
Voluntarily (not) wearing a face mask (cotton or surgical) for 4 hours, following the government's guidelines during the COVID-19 pandemic.
| Study group | Role | What they receive |
|---|---|---|
| No face mask | Volunteers who did not wear a face mask Receives: 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. Receives: 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. Receives: Other: Observational intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in microbiome composition of the skin and upper airways after wearing a face mask
16S rRNA sequencing
Measured: Start, 4 hours
Optimalization of microbiome analysis of skin and upper airway samples
16S rRNA sequencing, shotgun metagenomic sequencing
Measured: Start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2021
- Study start15 Mar 2021
- Primary completion31 Dec 2021 (estimated)
- Study completion15 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University Hospital, AntwerpThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Collaborators
- Universiteit Antwerpen
- Responsible party
- Principal investigator, Sarah Lebeer, University Hospital, Antwerp
- Investigators
- Sarah Lebeer, Prof., Principal investigator, Universiteit Antwerpen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04894422
- Sponsor's protocol ID
- B3002021000072
- Status last verified
- May 2021
- First submitted
- 11 May 2021
- Last updated
- 20 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Face Masks on the Microbial Communities of the Skin and Upper Airways and the Optimalisation of Microbiome Analysis
- ClinicalTrials.gov ID
- NCT04894422
- Acronym / sponsor ID
- B3002021000072
- Conditions
- Healthy
- Keywords
- skin microbiome, 16S amplicon sequencing, face masks, upper airway microbiome, shotgun sequencing
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Collaborators
- Universiteit Antwerpen
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 15 Mar 2023 (estimated)
- First posted
- 20 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No face mask | – | Other: Observational interventionVolunteers who did not wear a face mask |
| Cotton face mask | – | Other: Observational interventionVoluntarily wearing a cotton face mask for 4 hours, following the government's guidelines during the COVID-19 pandemic. |
| Surgical face mask | – | Other: Observational interventionVoluntarily wearing a surgical face mask for 4 hours, following the government's guidelines during the COVID-19 pandemic. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy, adult volunteers
Key inclusion criteria (1 listed)
- Adult age 18 at the start of the study
Key exclusion criteria (1 listed)
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational interventionVoluntarily (not) wearing a face mask (cotton or surgical) for 4 hours, following the government's guidelines during the COVID-19 pandemic. | Other | Cotton face mask, No face mask, Surgical face mask |
Primary outcome
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
Optimalization of microbiome analysis of skin and upper airway samples
Time frame: Start
16S rRNA sequencing, shotgun metagenomic sequencing
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Lebeer, Prof. principal investigator
Universiteit Antwerpen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by University Hospital, Antwerp at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sarah Lebeer, Prof. (+3232653285, sarah.lebeer@uantwerpen.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in microbiome composition of the skin and upper airways after wearing a face mask (time frame: Start, 4 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2021.