Human Skin and Gut Mycobiome and Bacteriome Comprehensive Registry

Study Overview
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Brief Summary
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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
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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.

Official Title
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Human Skin and Gut Mycobiome and Bacteriome Comprehensive Registry

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Other: Questionnaire
* Other: Stool sample
* Other: Skin swab
* Other: Oral rinse


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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|
|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|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 |