Recruiting

Microbiome Profiles

Sponsor:

University Hospitals Cleveland Medical Center

Code:

NCT05196061

Conditions

Healthy Volunteers

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Questionnaire

Stool sample

Skin swab

Oral rinse

Study Details

Brief summary:

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.

Conditions

Healthy Volunteers

Study ID

NCT05196061

Start date

Jan 1, 2020

Status verified date

Apr, 2026

Completion date

Dec 31, 2030

Anticipated

Primary completion date

Dec 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

5000 participants

Anticipated

Interventions and Outcome Measures

Interventions

Questionnaire

Subjects will be asked to complete a questionnaire. The questionnaire will garner demographic data, medical history, medication and supplement history, gut-specific, skin-specific questions; etc. The complete questionnaire is provided with this submission for review. Demographic data includes:

1. Age
2. Sex
3. Race
4. Ethnicity

Stool sample

Stool samples will be collected using a specific kit consisting of a ready-to-use package, including a user guide. When stool samples are collected, they will be immediately placed in previously prepared Fast prep tubes (MP, Cat# 5076-200-34340) containing 500 μL glass beads (Sigma-Aldrich G8772-100g) and 1 mL ASL™ lysis buffer (Qiagen DNA Extraction Kit) and transported to the laboratory where assays will be conducted. Samples will be kept in a - 20 degree Celsius freezer until they are analyzed.

Skin swab

Skin swabbing is a safe, non-invasive method to sample microbiota on human skin. Areas to be swabbed: Right upper back, Non-dominant ventral forearm or Most representative lesion

Oral rinse

Briefly, 20-25 ml saline will be provided in separately labelled blue capped 50-mL Falcon™ centrifuge tubes (Fisher Scientifics Co.). Each subject will be asked to swish and gargled the saline from the tube into their mouth for 2 minutes and expectorate the rinse into the tube. The tubes will be closed tightly and stored in -80 C until sequencing can be completed. Prior to use, all the tubes with oral wash samples will be completely thawed on ice, then centrifuged at 4000 rpm for 15 minutes and 20-25 ml supernatant transferred into fresh 50-mL centrifuge tubes. The pellet left in each tube will be used to extract DNA for microbiome studies

Primary outcome measure

  • whole-body and site-specific microbiome profiles [ Time Frame: 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 ]
  • bacterial-bacterial, fungal-fungal and bacterial-fungal correlation analysis [ Time Frame: through study completion, an average of 10 year ]

Central Contacts and Locations

Central contacts

Mahmoud Ghannoum, PhD

216-844-7834mahmoud.ghannoum@uhhospitals.org

Locations

University Hospitals Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

More Information

Sponsor

University Hospitals Cleveland Medical Center

Last update posted

Apr 13, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Hospitals Cleveland Medical Center on 2026-04-13.