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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Water rinse | Placebo Comparator | rinse twice daily for 1 min with water |
|
| Lumineux Oral Essentials rinse | Experimental | rinse twice daily for 1 min with Lumineux Oral Essentials rinse |
|
| Listerine rinse | Experimental | rinse twice daily for 1 min with Listerine rinse |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lumineux Oral Essentials rinse | Other | mouthrinse |
| |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nicole Wakida, PhD | Contact | 949-824-4360 | nwakida@uci.edu |
| Name | Affiliation | Role |
|---|---|---|
| Petra Wilder-Smith, DDS, PhD | University of Calfornia Irvine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beckman Laser Institute and Medical Clinic | Recruiting | Irvine | California | 92612 | United States |
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| ID | Term |
|---|---|
| D003141 | Communicable Diseases |
| D014777 | Virus Diseases |
| ID | Term |
|---|---|
| D007239 | Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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White tape over receptacle
| Listerine rinse |
| Other |
mouthrinse |
|
| 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 |