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Efficacy of VRx MyBiotics Oral Lozenges

Sponsor
Viome (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05972330
Collaborator
(none)
31
Enrollment
1
Location
1
Arm
7.2
Anticipated Duration (Months)
4.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: VRx MyBiotics Oral Lozenges
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
31 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Participants will be assigned an oral lozenge formulation based on the baseline analysis of their oral microbiome.Participants will be assigned an oral lozenge formulation based on the baseline analysis of their oral microbiome.
Masking:
None (Open Label)
Masking Description:
None, Open Label
Primary Purpose:
Supportive Care
Official Title:
Testing the Efficacy of VRx MyBiotics Oral Lozenges to Improve the Oral Microbiome
Actual Study Start Date :
Jun 26, 2023
Anticipated Primary Completion Date :
Feb 1, 2024
Anticipated Study Completion Date :
Feb 1, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Viome Oral Health Score [~ 4 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Viome Life Sciences Bothell Washington United States 98011

Sponsors and Collaborators

  • Viome

Investigators

  • Principal Investigator: Momchilo Vuyisich, Viome

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Viome
ClinicalTrials.gov Identifier:
NCT05972330
Other Study ID Numbers:
  • V308
First Posted:
Aug 2, 2023
Last Update Posted:
Aug 2, 2023
Last Verified:
Jul 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Viome
oral health
oral lozenge
oral microbiome

Study Results

No Results Posted as of Aug 2, 2023