Healthy Volunteers
Conditions
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.
Interventions
OTHERQuestionnaire
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
OTHERStool 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.
OTHERSkin 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
OTHEROral 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
University Hospitals Cleveland Medical Center
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| whole-body and site-specific microbiome profiles | through study completion, an average of 10 year | Identify and characterize whole-body and site-specific microbiome profiles. |
| Phenotypic microbiome profiles unique to individual parameters | through study completion, an average of 10 year | Identify phenotypic microbiome profiles unique to individual parameters such as demographics, medical diagnoses, diet; etc. |
| bacterial-bacterial, fungal-fungal and bacterial-fungal correlation analysis | 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. |
Countries
United States
Contacts
Primary ContactMahmoud Ghannoum, PhD
Outcome results
None listed