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Study of the Human Skin Microbiome

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ClinicalTrials.gov Identifier: NCT00764608
Recruitment Status : Withdrawn (No Participants enrolled, per PI discretion)
First Posted : October 2, 2008
Last Update Posted : November 26, 2015
Sponsor:
Information provided by (Responsible Party):
Randall Wolcott, Southwest Regional Wound Care Center

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.

Condition or disease
Healthy

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 Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Study of the Human Skin Microbiome
Study Start Date : June 2008
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009

Group/Cohort
No Treatment



Primary Outcome Measures :
  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. [ Time Frame: 2 years ]

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.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: October 2, 2008    Key Record Dates
Last Update Posted: November 26, 2015
Last Verified: November 2015