Study of the Human Skin Microbiome

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Randall Wolcott, Southwest Regional Wound Care Center
ClinicalTrials.gov Identifier:
NCT00764608
First received: September 30, 2008
Last updated: September 13, 2011
Last verified: September 2011
  Purpose

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.


Condition
Healthy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Study of the Human Skin Microbiome

Further study details as provided by Southwest Regional Wound Care Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

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.


Enrollment: 0
Study Start Date: June 2008
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
No Treatment

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Subjects cannot be 17 years of age or younger.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00764608

Locations
United States, Texas
Southwest Regional Wound Care Center
Lubbock, Texas, United States, 79410
Sponsors and Collaborators
Southwest Regional Wound Care Center
Investigators
Principal Investigator: Randall Wolcott, MD Southwest Regional Wound Care Center
  More Information

No publications provided

Responsible Party: Randall Wolcott, Prinicipal Investigator, Southwest Regional Wound Care Center
ClinicalTrials.gov Identifier: NCT00764608     History of Changes
Other Study ID Numbers: 56-RW-012
Study First Received: September 30, 2008
Last Updated: September 13, 2011
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on April 21, 2014