Oral Bacterial InfectionMicrobiomeNCT05603650
Effects of Mouthrinse on the Microbiome of the Oral Cavity and GI Tract
A study testing Lumineux Oral Essentials rinse and Listerine rinse in people with Oral Bacterial Infection and Oral Infection, run by University of California, Irvine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Oral Bacterial Infection, Oral Infection, Microbial Colonization
- What is being tested?
- Lumineux Oral Essentials rinse and Listerine rinse
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2021to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Beckman Laser Institute and Medical Clinic
Irvine, California, 92612
Nicole Wakida, PhD, 949-824-4360, nwakida@uci.edu
Petra Wilder-Smith, DDS, PhD
About this study
Official title: Effects of Mouthrinses on the Microbiome of the Oral Cavity and GI Tract
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.
Read the 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.
- Being tested
- Lumineux Oral Essentials rinse, Listerine rinse
- Keywords
- Oral Microbiome, Fecal Microbiome
- Medical subject headings
- Communicable Diseases, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumineux Oral Essentials rinseOther
mouthrinse
Listerine rinseOther
mouthrinse
| Study group | Role | What they receive |
|---|---|---|
| Water rinse | Placebo comparator | rinse twice daily for 1 min with water Receives: Other: Lumineux Oral Essentials rinse; Other: Listerine rinse |
| Lumineux Oral Essentials rinse | Experimental | rinse twice daily for 1 min with Lumineux Oral Essentials rinse Receives: Other: Listerine rinse |
| Listerine rinse | Experimental | rinse twice daily for 1 min with Listerine rinse Receives: Other: Lumineux Oral Essentials rinse |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Day 180
viral load and mRNA analysis using RT-PCR
viral load: HSV1, CMV, EBV
Measured: Day 0
viral load and mRNA analysis using RT-PCR
viral load: HSV1, CMV, EBV
Measured: Day 30
viral load and mRNA analysis using RT-PCR
viral load: HSV1, CMV, EBV
Measured: Day 60
viral load and mRNA analysis using RT-PCR
viral load: HSV1, CMV, EBV
Measured: Day 90
viral load and mRNA analysis using RT-PCR
viral load: HSV1, CMV, EBV
Measured: Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2022
- Study start1 Sep 2021
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Bacterial InfectionStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Petra E. Wilder-Smith, University of California, Irvine
- Investigators
- Petra Wilder-Smith, DDS, PhD, Principal investigator, University of Calfornia Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05603650
- Sponsor's protocol ID
- 20205719
- Acronym
- Microbiome
- Status last verified
- Dec 2025
- First submitted
- 12 Sep 2022
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Mouthrinses on the Microbiome of the Oral Cavity and GI Tract
- ClinicalTrials.gov ID
- NCT05603650
- Acronym / sponsor ID
- Microbiome / 20205719
- Keywords
- Oral Microbiome, Fecal Microbiome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 3 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Water rinse | Placebo comparator | Other: Lumineux Oral Essentials rinse, Other: Listerine rinserinse twice daily for 1 min with water |
| Lumineux Oral Essentials rinse | Experimental | Other: Listerine rinserinse twice daily for 1 min with Lumineux Oral Essentials rinse |
| Listerine rinse | Experimental | Other: Lumineux Oral Essentials rinserinse twice daily for 1 min with Listerine rinse |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lumineux Oral Essentials rinsemouthrinse | Other | Listerine rinse, Water rinse |
| Listerine rinsemouthrinse | Other | Lumineux Oral Essentials rinse, Water rinse |
Primary outcome
total bacterial load and mRNA analysis
Time frame: Day 0
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
Time frame: Day 30
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
Time frame: Day 60
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
Time frame: Day 90
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
Time frame: Day 180
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
Time frame: Day 0
viral load: HSV1, CMV, EBV
viral load and mRNA analysis using RT-PCR
Time frame: Day 30
viral load: HSV1, CMV, EBV
viral load and mRNA analysis using RT-PCR
Time frame: Day 60
viral load: HSV1, CMV, EBV
viral load and mRNA analysis using RT-PCR
Time frame: Day 90
viral load: HSV1, CMV, EBV
viral load and mRNA analysis using RT-PCR
Time frame: Day 180
viral load: HSV1, CMV, EBV
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Petra Wilder-Smith, DDS, PhD principal investigator
University of Calfornia Irvine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lumineux Oral Essentials rinse and Listerine rinse in people with Oral Bacterial Infection and Oral Infection, run by University of California, Irvine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicole Wakida, PhD (949-824-4360, nwakida@uci.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
total bacterial load and mRNA analysis (time frame: Day 0). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.