Efficacy of VRx MyBiotics Oral Lozenges

Not Applicable

Completed

• Conditions: Oral Microbiome Health
• Interventions: Dietary Supplement: VRx MyBiotics Oral Lozenges

• Registration Number: NCT05972330
• Lead Sponsor: Viome

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.

Study Timeline

• Study Start: 2023-06-26
• Study First Submitted: 2023-07-24
• Study First Submitted QC: 2023-07-24
• Study First Posted: 2023-08-02
• Primary Completion: 2024-01-26
• Study Completion: 2024-01-26
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-08
• Last Update Posted: 2024-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
VRx MyBiotics Oral Lozenges	VRx MyBiotics Oral Lozenges	Participants will receive a 30 day supply of their personalized oral biotic lozenges.

Primary Outcome Measures

Name	Time	Method
Viome Oral Health Score	~ 4 months	Increase in oral health score as measured by Viome's Oral Health Score.

Trial Locations

Locations (1)

Viome Life Sciences; 🇺🇸 Bothell, Washington, United States