- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05196061
Human Skin and Gut Mycobiome and Bacteriome Comprehensive Registry
April 7, 2026 updated by: University Hospitals Cleveland Medical Center
Bacterial and fungal microbiota will be different between individual body sites; however, particular microbiome profiles both whole-body and site-specific will be unique to volunteers with a given parameter such as medical diagnosis, diet, medications taken, geographical area; etc.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Specific aims:
- Identify and characterize whole-body and site-specific microbiome profiles.
- Identify phenotypic microbiome profiles unique to individual parameters such as demographics, medical diagnoses, diet; etc.
- Perform bacterial-bacterial, fungal-fungal and bacterial-fungal correlation analysis to identify potential synergistic and antagonistic species within these unique profiles.
Study Type
Observational
Enrollment (Estimated)
5000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Mahmoud Ghannoum, PhD
- Phone Number: 216-844-7834
- Email: mahmoud.ghannoum@uhhospitals.org
Study Locations
-
-
Ohio
-
Cleveland, Ohio, United States, 44106
- Recruiting
- University Hospitals Cleveland Medical Center
-
Contact:
- Mahmoud Ghannoum, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Volunteers will be age 18 years or older and capable of giving informed consent and able and willing to complete all required study specified procedures
Description
Inclusion Criteria:
- Capable of giving informed consent.
- Able and willing to complete all required specified study procedures
Exclusion Criteria:
- Antibiotic or antifungal use whether topical or systemic in the past 2 or 4 weeks, respectively.
- Unable and/or unwilling to complete all required study procedures.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
whole-body and site-specific microbiome profiles
Time Frame: through study completion, an average of 10 year
|
Identify and characterize whole-body and site-specific microbiome profiles.
|
through study completion, an average of 10 year
|
|
Phenotypic microbiome profiles unique to individual parameters
Time Frame: through study completion, an average of 10 year
|
Identify phenotypic microbiome profiles unique to individual parameters such as demographics, medical diagnoses, diet; etc.
|
through study completion, an average of 10 year
|
|
bacterial-bacterial, fungal-fungal and bacterial-fungal correlation analysis
Time Frame: through study completion, an average of 10 year
|
Perform bacterial-bacterial, fungal-fungal and bacterial-fungal correlation analysis to identify potential synergistic and antagonistic species within these unique profiles.
|
through study completion, an average of 10 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Muszer M, Noszczynska M, Kasperkiewicz K, Skurnik M. Human Microbiome: When a Friend Becomes an Enemy. Arch Immunol Ther Exp (Warsz). 2015 Aug;63(4):287-98. doi: 10.1007/s00005-015-0332-3. Epub 2015 Feb 15.
- Ackerman J. The ultimate social network. Sci Am. 2012 Jun;306(6):36-43. doi: 10.1038/scientificamerican0612-36. No abstract available.
- Proctor LM. The Human Microbiome Project in 2011 and beyond. Cell Host Microbe. 2011 Oct 20;10(4):287-91. doi: 10.1016/j.chom.2011.10.001.
- Ursell LK, Metcalf JL, Parfrey LW, Knight R. Defining the human microbiome. Nutr Rev. 2012 Aug;70 Suppl 1(Suppl 1):S38-44. doi: 10.1111/j.1753-4887.2012.00493.x.
- Dave M, Higgins PD, Middha S, Rioux KP. The human gut microbiome: current knowledge, challenges, and future directions. Transl Res. 2012 Oct;160(4):246-57. doi: 10.1016/j.trsl.2012.05.003. Epub 2012 Jun 7.
- Grice EA, Kong HH, Conlan S, Deming CB, Davis J, Young AC; NISC Comparative Sequencing Program; Bouffard GG, Blakesley RW, Murray PR, Green ED, Turner ML, Segre JA. Topographical and temporal diversity of the human skin microbiome. Science. 2009 May 29;324(5931):1190-2. doi: 10.1126/science.1171700.
- Mukherjee PK, Chandra J, Retuerto M, Tatsuoka C, Ghannoum MA, McComsey GA. Dysbiosis in the oral bacterial and fungal microbiome of HIV-infected subjects is associated with clinical and immunologic variables of HIV infection. PLoS One. 2018 Jul 11;13(7):e0200285. doi: 10.1371/journal.pone.0200285. eCollection 2018.
- Grice EA, Segre JA. The skin microbiome. Nat Rev Microbiol. 2011 Apr;9(4):244-53. doi: 10.1038/nrmicro2537.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2020
Primary Completion (Estimated)
December 31, 2030
Study Completion (Estimated)
December 31, 2030
Study Registration Dates
First Submitted
December 15, 2021
First Submitted That Met QC Criteria
January 4, 2022
First Posted (Actual)
January 19, 2022
Study Record Updates
Last Update Posted (Actual)
April 13, 2026
Last Update Submitted That Met QC Criteria
April 7, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Health Care Quality, Access, and Evaluation
- Investigative Techniques
- Epidemiologic Methods
- Chemical Actions and Uses
- Data Collection
- Health Care Evaluation Mechanisms
- Quality of Health Care
- Public Health
- Environment and Public Health
- Biomedical and Dental Materials
- Manufactured Materials
- Technology, Industry, and Agriculture
- Specialty Uses of Chemicals
- Cosmetics
- Surveys and Questionnaires
- Mouthwashes
Other Study ID Numbers
- STUDY20191290
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
results will not be shared with other researchers
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.