Effects of Mouthrinse on the Microbiome of the Oral Cavity and GI Tract
Microbiome
Effects of Mouthrinses on the Microbiome of the Oral Cavity and GI Tract
1 other identifier
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2021
CompletedFirst Submitted
Initial submission to the registry
September 12, 2022
CompletedFirst Posted
Study publicly available on registry
November 3, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
December 17, 2025
December 1, 2025
6.3 years
September 12, 2022
December 16, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (10)
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
Study Arms (3)
Water rinse
PLACEBO COMPARATORrinse twice daily for 1 min with water
Lumineux Oral Essentials rinse
EXPERIMENTALrinse twice daily for 1 min with Lumineux Oral Essentials rinse
Listerine rinse
EXPERIMENTALrinse twice daily for 1 min with Listerine rinse
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beckman Laser Institute and Medical Clinic
Irvine, California, 92612, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Petra Wilder-Smith, DDS, PhD
University of Calfornia Irvine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- White tape over receptacle
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Surgery and Director of Dentistry
Study Record Dates
First Submitted
September 12, 2022
First Posted
November 3, 2022
Study Start
September 1, 2021
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
December 17, 2025
Record last verified: 2025-12