Effects of Mouthrinse on the Microbiome of the Oral Cavity and GI Tract

Part of paid clinical trials in Irvine, California.

Sponsor
University of California, Irvine
Study ID
NCT05603650
Status
Recruiting
Apply to this trial

Conditions

  • Microbial Colonization
  • Oral Bacterial Infection
  • Oral Infection
  • Viral Infection

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Lumineux Oral Essentials rinse — OTHER
    mouthrinse
  • Listerine rinse — OTHER
    mouthrinse

Study Details

The purpose of this research study is to identify the effects of 2 over-the-counter mouthwashes on bacteria and 3 viruses in the participant's mouth and gut. The participant will be randomly allocated to rinse their mouth twice daily either with Listerine mouthwash, Lumineux Oral Essentials mouthwash, or water. The overall duration of the study will be approximately 180 days and will include approximately 5 visits and 15-30 minutes for each visit with a total of approximately 2.5 hours of your time. Additionally, fecal matter will also be collected in some subjects using a commercial collection kit.

Key Dates

Start date
Sep 1, 2021
Status verified
Dec 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Placebo Comparator: Water rinse
    rinse twice daily for 1 min with water
  • Experimental: Lumineux Oral Essentials rinse
    rinse twice daily for 1 min with Lumineux Oral Essentials rinse
  • Experimental: Listerine rinse
    rinse twice daily for 1 min with Listerine rinse

Primary Outcome Measure

total bacterial load and mRNA analysis [ Time Frame: Day 0 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Beckman Laser Institute and Medical ClinicIrvineCalifornia92612
Nicole Wakida, PhD
[email protected]
949-824-4360
Petra Wilder-Smith, DDS, PhD (PRINCIPAL_INVESTIGATOR)

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Beckman Laser Institute and Medical Clinic· Irvine, CA

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