NCT05196061

Human Skin and Gut Mycobiome and Bacteriome Comprehensive Registry

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 5,000 (estimated)
• Sponsor: University Hospitals Cleveland Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
OTHER	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
OTHER	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.
OTHER	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
OTHER	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

Timeline

• Start date: 2020-01-01
• Primary completion: 2030-12-31
• Completion: 2030-12-31
• First posted: 2022-01-19
• Last updated: 2026-04-13

Locations

1 site across 1 country: United States