Human Skin and Gut Mycobiome and Bacteriome Comprehensive Registry

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

Detailed Description

Specific aims:

  1. Identify and characterize whole-body and site-specific microbiome profiles.
  2. Identify phenotypic microbiome profiles unique to individual parameters such as demographics, medical diagnoses, diet; etc.
  3. 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

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

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

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.

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