NCT05603650

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: University of California, Irvine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Oral Bacterial Infection
• Oral Infection
• Microbial Colonization
• Viral Infection

Interventions

Type	Name	Description
OTHER	Lumineux Oral Essentials rinse	mouthrinse
OTHER	Listerine rinse	mouthrinse

Timeline

• Start date: 2021-09-01
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2022-11-03
• Last updated: 2025-12-17

Locations

1 site across 1 country: United States