Effects of Mouthrinses on the Microbiome of the Oral Cavity and GI Tract (Microbiome)

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.

Study Overview

• Status: Recruiting
• Conditions: Microbial Colonization; Oral Infection; Oral Bacterial Infection; Viral Infection
• Intervention / Treatment: Other: Lumineux Oral Essentials rinse; Other: Listerine rinse

Detailed Description

Goal of this pilot study is to identify the effects of 2 over-the-counter mouthrinses on the microbiome of the oral cavity and the GI tract. We will investigate 2 mouthwashes, plus an additional non-treatment group (water rinse only). One mouthwash has antimicrobial activity (ListerineR, Johnson & Johnson Consumer Healthcare Products, Skillman, New Jersey); the other targets microbial products only (Lumineux Oral Essentials Clean and Fresh MouthwashR, Los Angeles, CA). Oral plaque will be collected with a sterile swab using a commercial collection kit on Day 0, Day 30, Day 60, Day 90, and Day 180 of the study. Additionally, fecal matter will also be collected in some subjects using a commercial collection kit. Subjects will rinse 2x daily for approximately 180 days using either mouthwash or water.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nicole Wakida, PhD; Phone Number: 949-824-4360; Email: nwakida@uci.edu

Study Locations

• United States
  • California
    • Irvine, California, United States, 92612
      • Recruiting
      • Beckman Laser Institute and Medical Clinic
      • Principal Investigator: Petra Wilder-Smith, DDS, PhD
      • Contact: Nicole Wakida, PhD; Phone Number: 949-824-4360; Email: nwakida@uci.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Eligible men and non-pregnant and non-lactating women of all races age 18-25.
• Volunteers must consent to participate in all scheduled exam visits and procedures.
• Volunteers must be available for follow up on the telephone.
• Healthy gums or gums that bleed when you brush them.

Exclusion Criteria:

• Volunteers unable or unwilling to sign the informed consent form.
• Less than 20 teeth (excluding third molars).
• Individuals who have taken antibiotics in the previous 3 months.
• Presence of any condition, abnormality, or situation at Baseline that in the opinion of the Principal Investigator may preclude the volunteer's ability to comply with study requirements, including completion of the study or the quality of the data.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Water rinse; rinse twice daily for 1 min with water	Other: Lumineux Oral Essentials rinse; mouthrinse; Other: Listerine rinse; mouthrinse
Experimental: Lumineux Oral Essentials rinse; rinse twice daily for 1 min with Lumineux Oral Essentials rinse	Other: Listerine rinse; mouthrinse
Experimental: Listerine rinse; rinse twice daily for 1 min with Listerine rinse	Other: Lumineux Oral Essentials rinse; mouthrinse

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
total bacterial load and mRNA analysis	total bacterial load as determined from oral swabs and collected fecal samples, followed by subsequent standard mRNA analysis using RT-PCR	Day 0
total bacterial load and mRNA analysis	total bacterial load as determined from oral swabs and collected fecal samples, followed by subsequent standard mRNA analysis using RT-PCR	Day 30
total bacterial load and mRNA analysis	total bacterial load as determined from oral swabs and collected fecal samples, followed by subsequent standard mRNA analysis using RT-PCR	Day 60
total bacterial load and mRNA analysis	total bacterial load as determined from oral swabs and collected fecal samples, followed by subsequent standard mRNA analysis using RT-PCR	Day 90
total bacterial load and mRNA analysis	total bacterial load as determined from oral swabs and collected fecal samples, followed by subsequent standard mRNA analysis using RT-PCR	Day 180
viral load and mRNA analysis using RT-PCR	viral load: HSV1, CMV, EBV	Day 0
viral load and mRNA analysis using RT-PCR	viral load: HSV1, CMV, EBV	Day 30
viral load and mRNA analysis using RT-PCR	viral load: HSV1, CMV, EBV	Day 60
viral load and mRNA analysis using RT-PCR	viral load: HSV1, CMV, EBV	Day 90
viral load and mRNA analysis using RT-PCR	viral load: HSV1, CMV, EBV	Day 180

Collaborators and Investigators

• Sponsor: University of California, Irvine
• Investigators: Principal Investigator: Petra Wilder-Smith, DDS, PhD, University of Calfornia Irvine

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: September 12, 2022
• First Submitted That Met QC Criteria: October 27, 2022
• First Posted (Actual): November 3, 2022

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Oral Microbiome; Fecal Microbiome
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Bacterial Infections and Mycoses; Infections; Communicable Diseases; Virus Diseases; Bacterial Infections; Anti-Infective Agents, Local; Anti-Infective Agents; Listerine
• Other Study ID Numbers: 20205719

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No