NCT00764608

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2008

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 30, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 2, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

November 26, 2015

Status Verified

November 1, 2015

Enrollment Period

8 months

First QC Date

September 30, 2008

Last Update Submit

November 24, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    2 years

Study Arms (1)

No Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

It is the goal of the study to survey multiple skin locations of humans at multiple time points

You may qualify if:

  • 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.

You may not qualify if:

  • Subjects cannot be 17 years of age or younger.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southwest Regional Wound Care Center

Lubbock, Texas, 79410, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

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 Officials

  • Randall Wolcott, MD

    Southwest Regional Wound Care Center

    PRINCIPAL INVESTIGATOR
0

Study Design

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

Study Record Dates

First Submitted

September 30, 2008

First Posted

October 2, 2008

Study Start

June 1, 2008

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

November 26, 2015

Record last verified: 2015-11

Locations