Clinical trial NCT05196061: Human Skin and Gut Mycobiome and Bacteriome Comprehensive Registry
Official title: Human Skin and Gut Mycobiome and Bacteriome Comprehensive Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Healthy Volunteers
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
First posted: 2022-01-19
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Volunteers will be age 18 years or older and capable of giving informed consent and able and willing to complete all required study specified procedures

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: whole-body and site-specific microbiome profiles
timeFrame: through study completion, an average of 10 year
measure: Phenotypic microbiome profiles unique to individual parameters
timeFrame: through study completion, an average of 10 year
measure: bacterial-bacterial, fungal-fungal and bacterial-fungal correlation analysis
timeFrame: through study completion, an average of 10 year
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
Study officials:
References:
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.
citation: Ackerman J. The ultimate social network. Sci Am. 2012 Jun;306(6):36-43. doi: 10.1038/scientificamerican0612-36. No abstract available.
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.
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.
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.
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;324(5931):1190-2. doi: 10.1126/science.1171700.
citation: Grice EA, Segre JA. The skin microbiome. Nat Rev Microbiol. 2011 Apr;9(4):244-53. doi: 10.1038/nrmicro2537.
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):e0200285. doi: 10.1371/journal.pone.0200285. eCollection 2018.