Human Skin and Gut Mycobiome and Bacteriome Comprehensive Registry
ConditionHealthy Volunteers
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospitals Cleveland Medical Center
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Capable of giving informed consent.
Able and willing to complete all required specified study procedures
Disqualifiers
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.
Trial 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
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Questionnaire
Other interventionSubjects 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
Stool sample
Other interventionStool 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 interventionSkin 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 interventionBriefly, 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
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
whole-body and site-specific microbiome profiles
Identify and characterize whole-body and site-specific microbiome profiles.
Time frame
through study completion, an average of 10 year2
Phenotypic microbiome profiles unique to individual parameters
Identify phenotypic microbiome profiles unique to individual parameters such as demographics, medical diagnoses, diet; etc.
Time frame
through study completion, an average of 10 year3
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.
Time frame
through study completion, an average of 10 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov