Microbial Colonization, Oral Bacterial Infection, Oral Infection, Viral Infection
Conditions
Keywords
Oral Microbiome, Fecal Microbiome
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.
Interventions
OTHERLumineux Oral Essentials rinse
mouthrinse
OTHERListerine rinse
mouthrinse
Sponsors
University of California, Irvine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Masking description
White tape over receptacle
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| total bacterial load and mRNA analysis | Day 0 | 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 | Day 0 | viral load: HSV1, CMV, EBV |
Countries
United States
Contacts
Primary ContactNicole Wakida, PhD
Outcome results
None listed