NCT05672953

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 20, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2021

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

December 21, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 5, 2023

Completed
Last Updated

January 5, 2023

Status Verified

December 1, 2022

Enrollment Period

3 months

First QC Date

December 21, 2022

Last Update Submit

December 21, 2022

Conditions

Oral Microbiome

Outcome Measures

Primary Outcomes (1)

  • Species richness in multiple oral locations

    Number of species present in different areas swabbed in the oral cavity.

    3 months

Secondary Outcomes (1)

  • KO richness of multiple oral locations

    3 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • years old or older

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Viome Life Sciences

Bothell, Washington, 98011, United States

Location

Study Officials

  • Momchilo Vuyisich

    Viome

    PRINCIPAL INVESTIGATOR

  • Guruduth Banavar

    Viome

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2022

First Posted

January 5, 2023

Study Start

May 20, 2021

Primary Completion

August 10, 2021

Study Completion

August 10, 2021

Last Updated

January 5, 2023

Record last verified: 2022-12

Locations

US(1)