Human Skin and Gut Mycobiome and Bacteriome Comprehensive Registry

Recruiting

• Conditions: Healthy Volunteers

• Registration Number: NCT05196061
• Lead Sponsor: University Hospitals Cleveland Medical Center

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.

Study Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2021-12-15
• Study First Submitted QC: 2022-01-04
• Study First Posted: 2022-01-19
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-07
• Last Update Posted: 2024-02-08
• Primary Completion: 2030-12-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

• Capable of giving informed consent.
• Able and willing to complete all required specified study procedures

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.
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.
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.

Trial Locations

Locations (1)

University Hospitals Cleveland Medical Center; 🇺🇸 Cleveland, Ohio, United States