Efficacy of VRx MyBiotics Oral Lozenges

NCT05972330 | Completed

• 1 other identifier: V308
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Oral Microbiome Health

Keywords

oral health; oral lozenge; oral microbiome

Outcome Measures

Primary Outcomes (1)

• Viome Oral Health Score

  Increase in oral health score as measured by Viome's Oral Health Score.

  ~ 4 months

Study Arms (1)

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

VRx MyBiotics Oral Lozenges DIETARY_SUPPLEMENT

VRx MyBiotics Oral Lozenges are composed of prebiotics, probiotics, and postbiotics.

VRx MyBiotics Oral Lozenges

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Viome: lead

Study Sites (1)

Viome Life Sciences

Bothell, Washington, 98011, United States

Location

Study Officials

• Momchilo Vuyisich

  Viome

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: None, Open Label
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will be assigned an oral lozenge formulation based on the baseline analysis of their oral microbiome.

Study Record Dates

• First Submitted: July 24, 2023
• First Posted: August 2, 2023
• Study Start: June 26, 2023
• Primary Completion: January 26, 2024
• Study Completion: January 26, 2024
• Last Updated: February 12, 2024

Record last verified: 2024-02

Locations

US (1)