Efficacy of VRx MyBiotics Oral Lozenges

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-26

Study Completion Date

2024-01-26

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Biogeography of the Oral Microbiome

NCT05672953

Oral Microbiome

COMPLETED

Safety and Efficacy of Oral Administration of the Phage Cocktail, VRELysin™, In Healthy and VRE-Colonized Subjects

NCT05715619

Vancomycin-Resistant Enterococcal Colonization

UNKNOWN PHASE1/PHASE2

Effect of Bismuth Subsalicylate on the Gut Microbiome and Host Response in Healthy Adults

NCT05930197

Healthy Adults

COMPLETED PHASE1

Safety and Tolerability of FMT Capsules in Healthy Volunteers

NCT05352269

Acute-graft-versus-host Disease

UNKNOWN PHASE1

Studies of the Human Microbiome in Clinical Center Patients

NCT01933620

Multidrug-resistant Colonization

ENROLLING_BY_INVITATION

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Oral Microbiome Health

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

None, Open Label

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

VRx MyBiotics Oral Lozenges

Participants will receive a 30 day supply of their personalized oral biotic lozenges.

Group Type EXPERIMENTAL

VRx MyBiotics Oral Lozenges

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

VRx MyBiotics Oral Lozenges

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes