HealthyNCT00764608
Study of the Human Skin Microbiome
An observational study of Healthy, run by Southwest Regional Wound Care Center at 1 site in United States.
Trial summary
Numerous organisms live on and in healthy human skin. This study seeks to survey the diversity of this complex ecosystem by collecting samples from approximately 1000 individuals in order to determine the type of organisms living on their skin. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Feb 2009
- 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: It is the goal of the study to survey multiple skin locations of humans at multiple time points
Who may be able to join
- Subjects must be 18 years of age or older.
- Subjects must be able to consent for themselves.
- Must be willing to participate to a swab of the skin.
Who cannot join
- Subjects cannot be 17 years of age or younger.
Trial locations and contacts
1 site in 1 country.
United States1 site
Southwest Regional Wound Care Center
Lubbock, Texas, 79410
About this study
Numerous organisms live on and in healthy human skin. This study seeks to survey the diversity of this complex ecosystem by collecting samples from approximately 1000 individuals in order to determine the type of organisms living on their skin.
Read the detailed description
Subjects age 18 and above may be included in the study. It is the goal of the study to survey multiple skin locations of humans at multiple time points. The subjects' samples will be analyzed using DNA methods in order to identify the types of microbes present on the swabs. Other substances such as proteins, RNA, and other metabolites may also be analyzed. DNA or other molecular components of the sample will be extracted. Alternately, microbes in the sample can be cultured directly. The samples will be explored using molecular analyses. The backbone of the analyses will be shotgun metagenomic sequencing and 16S rDNA amplicon sequencing. The results of these analyses will be used to identify and describe the microbiome of the skin.
- Conditions
- Healthy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| No Treatment | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerous organisms live on and in healthy human skin. This study seeks to survey the diversity of this complex ecosystem by collecting samples from approximately 1000 individuals in order to determine the type of organisms living on their skin.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2008 (estimated)
- Study startJun 2008
- Primary completionFeb 2009
- Study completionFeb 2009
Why it stopped: No Participants enrolled, per PI discretion
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.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southwest Regional Wound Care Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Randall Wolcott, Southwest Regional Wound Care Center
- Investigators
- Randall Wolcott, MD, Principal investigator, Southwest Regional Wound Care Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00764608
- Sponsor's protocol ID
- 56-RW-012
- Status last verified
- Nov 2015
- First submitted
- 30 Sep 2008
- Last updated
- 26 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Human Skin Microbiome
- ClinicalTrials.gov ID
- NCT00764608
- Acronym / sponsor ID
- 56-RW-012
- Conditions
- Healthy
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No Participants enrolled, per PI discretion
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Southwest Regional Wound Care CenterUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 2 Oct 2008 (estimated)
- 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.
Numerous organisms live on and in healthy human skin. This study seeks to survey the diversity of this complex ecosystem by collecting samples from approximately 1000 individuals in order to determine the type of organisms living on their skin.
Detailed description
Subjects age 18 and above may be included in the study. It is the goal of the study to survey multiple skin locations of humans at multiple time points. The subjects' samples will be analyzed using DNA methods in order to identify the types of microbes present on the swabs. Other substances such as proteins, RNA, and other metabolites may also be analyzed. DNA or other molecular components of the sample will be extracted. Alternately, microbes in the sample can be cultured directly. The samples will be explored using molecular analyses. The backbone of the analyses will be shotgun metagenomic sequencing and 16S rDNA amplicon sequencing. The results of these analyses will be used to identify and describe the microbiome of the skin.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No Treatment | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- It is the goal of the study to survey multiple skin locations of humans at multiple time points
Key inclusion criteria (3 listed)
- Subjects must be 18 years of age or older.
- Subjects must be able to consent for themselves.
- Must be willing to participate to a swab of the skin.
Key exclusion criteria (1 listed)
- Subjects cannot be 17 years of age or younger.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Numerous organisms live on and in healthy human skin. This study seeks to survey the diversity of this complex ecosystem by collecting samples from approximately 1000 individuals in order to determine the type of organisms living on their skin.
Time frame: 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2015.
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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.
Randall Wolcott, MD principal investigator
Southwest Regional Wound Care Center
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 Southwest Regional Wound Care Center at 1 site in United States.
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 3 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: withdrawn, as of the sponsor's last update on 26 Nov 2015. 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 United States. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerous organisms live on and in healthy human skin. This study seeks to survey the diversity of this complex ecosystem by collecting samples from approximately 1000 individuals in order to determine the type of organisms living on their skin. (time frame: 2 years). 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 26 Nov 2015.