Effects of Mouthrinses on the Microbiome of the Oral Cavity and GI Tract

Microbial Colonization Clinical Trial

— Microbiome  

Official title:

Effects of Mouthrinses on the Microbiome of the Oral Cavity and GI Tract

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05603650
• Other study ID #: 20205719
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: December 2027

Study information

• Verified date: April 2024
• Source: University of California, Irvine
• Contact: Nicole Wakida, PhD
• Phone: 949-824-4360
• Email: nwakida[@]uci.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2027
• Est. primary completion date: December 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bacterial Infections
• Communicable Diseases
• Infections
• Microbial Colonization
• Oral Bacterial Infection
• Oral Infection
• Viral Infection
• Virus Diseases

Intervention

Other:
• Lumineux Oral Essentials rinse
mouthrinse
• Listerine rinse
mouthrinse

Locations

Country	Name	City	State
United States	Beckman Laser Institute and Medical Clinic	Irvine	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Irvine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	viral load and mRNA analysis using RT-PCR	viral load: HSV1, CMV, EBV	Day 0
Primary	viral load and mRNA analysis using RT-PCR	viral load: HSV1, CMV, EBV	Day 30
Primary	viral load and mRNA analysis using RT-PCR	viral load: HSV1, CMV, EBV	Day 60
Primary	viral load and mRNA analysis using RT-PCR	viral load: HSV1, CMV, EBV	Day 90
Primary	viral load and mRNA analysis using RT-PCR	viral load: HSV1, CMV, EBV	Day 180