Biogeography of the Oral Microbiome

Biogeography of the Oral Microbiome Using Metatranscriptomic Analyses

A cross-sectional study to metatranscriptomically analyze and compare the oral microbiome in different environmental niches within the oral cavity.

Study Overview

• Status: Completed
• Conditions: Oral Microbiome

Detailed Description

This study will collect samples from participants meeting the eligibility criteria over the span of 3 months. Samples will be collected from multiple locations within the oral cavity and metatranscriptomically analyzed.

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• United States
  • Washington
    • Bothell, Washington, United States, 98011
      • Viome Life Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The study population includes anyone that meets the inclusion criteria and does not have any exclusion criteria.

Description

Inclusion Criteria:

• 18 years old or older

Exclusion Criteria:

• Positive SARS-CoV-2 test result, if performed
• Antibiotic use in the previous 30 days
• Mouthwash use in the previous 6 months

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Species richness in multiple oral locations	Number of species present in different areas swabbed in the oral cavity.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
KO richness of multiple oral locations	KO richness of multiple areas swabbed in the oral cavity.	3 months

Collaborators and Investigators

• Sponsor: Viome
• Investigators: Principal Investigator: Momchilo Vuyisich, Viome

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2021
• Primary Completion (Actual): August 10, 2021
• Study Completion (Actual): August 10, 2021

Study Registration Dates

• First Submitted: December 21, 2022
• First Submitted That Met QC Criteria: December 21, 2022
• First Posted (Actual): January 5, 2023

Study Record Updates

• Last Update Posted (Actual): January 5, 2023
• Last Update Submitted That Met QC Criteria: December 21, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: V243

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No