Efficacy of VRx MyBiotics Oral Lozenges

Testing the Efficacy of VRx MyBiotics Oral Lozenges to Improve the Oral Microbiome

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

Study Overview

• Status: Completed
• Conditions: Oral Microbiome Health
• Intervention / Treatment: Dietary supplement: VRx MyBiotics Oral Lozenges

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.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Momchilo Vuyisich; Phone Number: (425) 300-6933; Email: studies@viome.com
• Study Contact Backup: Name: Kaitlyn Sells; Phone Number: (425) 300-6933; Email: studies@viome.com

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VRx MyBiotics Oral Lozenges; Participants will receive a 30 day supply of their personalized oral biotic lozenges.	Dietary supplement: VRx MyBiotics Oral Lozenges; VRx MyBiotics Oral Lozenges are composed of prebiotics, probiotics, and postbiotics.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2023
• Primary Completion (Actual): January 26, 2024
• Study Completion (Actual): January 26, 2024

Study Registration Dates

• First Submitted: July 24, 2023
• First Submitted That Met QC Criteria: July 24, 2023
• First Posted (Actual): August 2, 2023

Study Record Updates

• Last Update Posted (Actual): February 12, 2024
• Last Update Submitted That Met QC Criteria: February 8, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: oral health; oral microbiome; oral lozenge
• Other Study ID Numbers: V308

Drug and device information, study documents

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