Clinical trial NCT05603650: Effects of Mouthrinse on the Microbiome of the Oral Cavity and GI Tract
Official title: Effects of Mouthrinses on the Microbiome of the Oral Cavity and GI Tract
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Oral Bacterial Infection
Oral Infection
Microbial Colonization
Viral Infection
Keywords: Oral Microbiome
Fecal Microbiome
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2022-11-03
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: total bacterial load and mRNA analysis
timeFrame: Day 0
measure: total bacterial load and mRNA analysis
timeFrame: Day 30
measure: total bacterial load and mRNA analysis
timeFrame: Day 60
measure: total bacterial load and mRNA analysis
timeFrame: Day 90
measure: total bacterial load and mRNA analysis
timeFrame: Day 180
measure: viral load and mRNA analysis using RT-PCR
timeFrame: Day 0
measure: viral load and mRNA analysis using RT-PCR
timeFrame: Day 30
measure: viral load and mRNA analysis using RT-PCR
timeFrame: Day 60
measure: viral load and mRNA analysis using RT-PCR
timeFrame: Day 90
measure: viral load and mRNA analysis using RT-PCR
timeFrame: Day 180
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Beckman Laser Institute and Medical Clinic
state: California
Study officials:
affiliation: University of Calfornia Irvine
name: Petra Wilder-Smith, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References: