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Recruiting

NCT Number: NCT05196061

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.

Recruiting

Interested in participating?

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location status: Recruiting

Location contact

Mahmoud Ghannoum, PhD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Questionnaire

Other

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:

  • Age
  • Sex
  • Race
  • Ethnicity

Stool sample

Other

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

Other

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

Other

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 outcomes

  1. 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.

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mahmoud Ghannoum, PhD

CONTACT

[email protected]

216-844-7834

Sponsors and collaborators

Lead sponsor

University Hospitals Cleveland Medical Center

Other

Registry information

Important dates

Study start
2020
Primary completion
2030
Study completion
2030
First posted
Jan 19, 2022
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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