Efficacy of VRx MyBiotics Oral Lozenges | NCT05972330

Studies
Efficacy of VRx MyBiotics Oral Lozenges

NCT05972330

Sponsor

Viome

Status

Completed

Last Update Posted

Feb 12, 2024Actual

Enrollment

34Actual

Phase

Not Applicable

Conditions

Oral Microbiome Health

Interventions

VRx MyBiotics Oral Lozenges

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

Feb 2024

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

Jun 26, 2023Actual

Primary Completion Date

Jan 26, 2024Actual

Completion Date

Jan 26, 2024Actual

First Submitted Date

Jul 24, 2023

First Submission Date that Met QC Criteria

Jul 24, 2023

First Posted Date

Aug 2, 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

Feb 8, 2024

Last Update Posted Date

Feb 12, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

This study will test the efficacy of Viome's VRx MyBiotics Oral Lozenges at improving the oral microbiome.

Detailed Description

This is a single arm, interventional trial on adults residing in the United States. The study will test the efficacy of personalized oral biotic lozenges (VRx MyBiotics Oral Lozenges) at improving oral microbiome health according to Viome's Oral Health Score.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

34Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
VRx MyBiotics Oral Lozenges	Experimental	Participants will receive a 30 day supply of their personalized oral biotic lozenges.	Dietary Supplement: VRx MyBiotics Oral Lozenges

Interventions

Name	Type	Description	Arm Group Labels	Other Names
VRx MyBiotics Oral Lozenges	Dietary Supplement	VRx MyBiotics Oral Lozenges are composed of prebiotics, probiotics, and postbiotics.	VRx MyBiotics Oral Lozenges

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Viome Oral Health Score	Increase in oral health score as measured by Viome's Oral Health Score.	~ 4 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Any person with a US address that is 18 years old or older
Able to speak and read English
Willing and able to follow the trial instructions, as described in the recruitment letter
Signed and dated informed consent prior to any trial-specific procedures.

Exclusion Criteria:

Systemic antibiotic treatment 30 days prior to enrollment or during the trial
Not willing to stop sporadic use (less frequently than daily) of any mouthwash.
Significant diet, supplements, or lifestyle change in the previous 1 month or next 2 months once enrolled
Allergy to tapioca, peppermint, or sweet potato
Current diagnosis of periodontitis or other advanced oral disease (chronic recurrent caries, oral cancer, etc)
No dental procedures 30 days prior to enrollment or during the trial (regular cleanings, bone grafts, dental implants, etc)
Pregnancy or planned pregnancy
Currently have cancer or undergoing cancer therapy
Dentures
Fewer than 20 teeth
Use of at home teeth whitening products 30 days prior to enrollment or during the trial
Start new medications or supplements during the trial

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

Not provided

Sampling Method

Not provided