Human Skin and Gut Mycobiome and Bacteriome Comprehensive Registry

Healthy Volunteers Clinical Trial

Official title:

Human Skin and Gut Mycobiome and Bacteriome Comprehensive Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05196061
• Other study ID #: STUDY20191290
• Status: Recruiting
• Start date: January 1, 2020
• Est. completion date: December 31, 2030

Study information

• Verified date: February 2024
• Source: University Hospitals Cleveland Medical Center
• Contact: Mahmoud Ghannoum, PhD
• Phone: 216-844-7834
• Email: mahmoud.ghannoum[@]uhhospitals.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: December 31, 2030
• Est. primary completion date: December 31, 2030
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

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: Age Sex Race 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

Locations

Country	Name	City	State
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University Hospitals Cleveland Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (8)

Ackerman J. The ultimate social network. Sci Am. 2012 Jun;306(6):36-43. doi: 10.1038/scientificamerican0612-36. No abstract available. — View Citation

Dave M, Higgins PD, Middha S, Rioux KP. The human gut microbiome: current knowledge, challenges, and future directions. Transl Res. 2012 Oct;160(4):246-57. doi: 10.1016/j.trsl.2012.05.003. Epub 2012 Jun 7. — View Citation

Grice EA, Kong HH, Conlan S, Deming CB, Davis J, Young AC; NISC Comparative Sequencing Program; Bouffard GG, Blakesley RW, Murray PR, Green ED, Turner ML, Segre JA. Topographical and temporal diversity of the human skin microbiome. Science. 2009 May 29;32 — View Citation

Grice EA, Segre JA. The skin microbiome. Nat Rev Microbiol. 2011 Apr;9(4):244-53. doi: 10.1038/nrmicro2537. Erratum In: Nat Rev Microbiol. 2011 Aug;9(8):626. — View Citation

Mukherjee PK, Chandra J, Retuerto M, Tatsuoka C, Ghannoum MA, McComsey GA. Dysbiosis in the oral bacterial and fungal microbiome of HIV-infected subjects is associated with clinical and immunologic variables of HIV infection. PLoS One. 2018 Jul 11;13(7):e — View Citation

Muszer M, Noszczynska M, Kasperkiewicz K, Skurnik M. Human Microbiome: When a Friend Becomes an Enemy. Arch Immunol Ther Exp (Warsz). 2015 Aug;63(4):287-98. doi: 10.1007/s00005-015-0332-3. Epub 2015 Feb 15. — View Citation

Proctor LM. The Human Microbiome Project in 2011 and beyond. Cell Host Microbe. 2011 Oct 20;10(4):287-91. doi: 10.1016/j.chom.2011.10.001. — View Citation

Ursell LK, Metcalf JL, Parfrey LW, Knight R. Defining the human microbiome. Nutr Rev. 2012 Aug;70 Suppl 1(Suppl 1):S38-44. doi: 10.1111/j.1753-4887.2012.00493.x. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	whole-body and site-specific microbiome profiles	Identify and characterize whole-body and site-specific microbiome profiles.	through study completion, an average of 10 year
Primary	Phenotypic microbiome profiles unique to individual parameters	Identify phenotypic microbiome profiles unique to individual parameters such as demographics, medical diagnoses, diet; etc.	through study completion, an average of 10 year
Primary	bacterial-bacterial, fungal-fungal and bacterial-fungal correlation analysis	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