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

Primary Purpose

Oral Bacterial Infection, Oral Infection, Microbial Colonization

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lumineux Oral Essentials rinse
Listerine rinse
Sponsored by
University of California, Irvine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Oral Bacterial Infection focused on measuring Oral Microbiome, Fecal Microbiome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Beckman Laser InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Water rinse

Lumineux Oral Essentials rinse

Listerine rinse

Arm Description

rinse twice daily for 1 min with water

rinse twice daily for 1 min with Lumineux Oral Essentials rinse

rinse twice daily for 1 min with Listerine rinse

Outcomes

Primary Outcome Measures

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
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
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
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
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
viral load and mRNA analysis using RT-PCR
viral load: HSV1, CMV, EBV
viral load and mRNA analysis using RT-PCR
viral load: HSV1, CMV, EBV
viral load and mRNA analysis using RT-PCR
viral load: HSV1, CMV, EBV
viral load and mRNA analysis using RT-PCR
viral load: HSV1, CMV, EBV
viral load and mRNA analysis using RT-PCR
viral load: HSV1, CMV, EBV

Secondary Outcome Measures

Full Information

First Posted
September 12, 2022
Last Updated
October 27, 2022
Sponsor
University of California, Irvine
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1. Study Identification

Unique Protocol Identification Number
NCT05603650
Brief Title
Effects of Mouthrinses on the Microbiome of the Oral Cavity and GI Tract
Acronym
Microbiome
Official Title
Effects of Mouthrinses on the Microbiome of the Oral Cavity and GI Tract
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
December 31, 2027 (Anticipated)
Study Completion Date
December 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Irvine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Bacterial Infection, Oral Infection, Microbial Colonization, Viral Infection
Keywords
Oral Microbiome, Fecal Microbiome

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
White tape over receptacle
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Water rinse
Arm Type
Placebo Comparator
Arm Description
rinse twice daily for 1 min with water
Arm Title
Lumineux Oral Essentials rinse
Arm Type
Experimental
Arm Description
rinse twice daily for 1 min with Lumineux Oral Essentials rinse
Arm Title
Listerine rinse
Arm Type
Experimental
Arm Description
rinse twice daily for 1 min with Listerine rinse
Intervention Type
Other
Intervention Name(s)
Lumineux Oral Essentials rinse
Intervention Description
mouthrinse
Intervention Type
Other
Intervention Name(s)
Listerine rinse
Intervention Description
mouthrinse
Primary Outcome Measure Information:
Title
total bacterial load and mRNA analysis
Description
total bacterial load as determined from oral swabs and collected fecal samples, followed by subsequent standard mRNA analysis using RT-PCR
Time Frame
Day 0
Title
total bacterial load and mRNA analysis
Description
total bacterial load as determined from oral swabs and collected fecal samples, followed by subsequent standard mRNA analysis using RT-PCR
Time Frame
Day 30
Title
total bacterial load and mRNA analysis
Description
total bacterial load as determined from oral swabs and collected fecal samples, followed by subsequent standard mRNA analysis using RT-PCR
Time Frame
Day 60
Title
total bacterial load and mRNA analysis
Description
total bacterial load as determined from oral swabs and collected fecal samples, followed by subsequent standard mRNA analysis using RT-PCR
Time Frame
Day 90
Title
total bacterial load and mRNA analysis
Description
total bacterial load as determined from oral swabs and collected fecal samples, followed by subsequent standard mRNA analysis using RT-PCR
Time Frame
Day 180
Title
viral load and mRNA analysis using RT-PCR
Description
viral load: HSV1, CMV, EBV
Time Frame
Day 0
Title
viral load and mRNA analysis using RT-PCR
Description
viral load: HSV1, CMV, EBV
Time Frame
Day 30
Title
viral load and mRNA analysis using RT-PCR
Description
viral load: HSV1, CMV, EBV
Time Frame
Day 60
Title
viral load and mRNA analysis using RT-PCR
Description
viral load: HSV1, CMV, EBV
Time Frame
Day 90
Title
viral load and mRNA analysis using RT-PCR
Description
viral load: HSV1, CMV, EBV
Time Frame
Day 180

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dr. Petra Wilder-Smith
Phone
949-824-7632
Email
pwsmith@uci.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Hanna Kim
Phone
949-824-2251
Email
hhkim3@uci.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Petra Wilder-Smith
Organizational Affiliation
Beckman Laser Institute University of California Irvine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beckman Laser Institute
City
Irvine
State/Province
California
ZIP/Postal Code
92612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hanna Kim
Phone
949-824-9265
Email
hhkim3@uci.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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

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