Biogeography of the Oral Microbiome | NCT05672953

Studies
Biogeography of the Oral Microbiome

NCT05672953

Sponsor

Viome

Status

Completed

Last Update Posted

Jan 5, 2023Actual

Enrollment

20Actual

Phase

Not provided

Conditions

Oral Microbiome

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 20, 2021Actual

Primary Completion Date

Aug 10, 2021Actual

Completion Date

Aug 10, 2021Actual

First Submitted Date

Dec 21, 2022

First Submission Date that Met QC Criteria

Dec 21, 2022

First Posted Date

Jan 5, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 21, 2022

Last Update Posted Date

Jan 5, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Momchilo Vuyisich	Viome	Principal Investigator
Guruduth Banavar	Viome	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Viome Life Sciences		Bothell	Washington	98011	United States