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Human Skin and Gut Mycobiome and Bacteriome Comprehensive Registry

NCT05196061 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 5000

Last updated 2026-04-13

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • University Hospitals Cleveland Medical Center

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-01-01
Primary Completion
2030-12-31
Completion
2030-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05196061 on ClinicalTrials.gov