Efficacy of VRx MyBiotics Oral Lozenges

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

Detailed Description
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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.

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

Conditions
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Oral Microbiome Health

Intervention / Treatment
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* Dietary Supplement: VRx MyBiotics Oral Lozenges


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: Participants will be assigned an oral lozenge formulation based on the baseline analysis of their oral microbiome.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VRx MyBiotics Oral Lozenges<br>Participants will receive a 30 day supply of their personalized oral biotic lozenges. | Dietary Supplement: VRx MyBiotics Oral Lozenges<br>* VRx MyBiotics Oral Lozenges are composed of prebiotics, probiotics, and postbiotics.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oral health, oral lozenge, oral microbiome