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

University of California Irvine (UCI)

Status: Enrolling

Conditions: Microbial Colonization; Oral Bacterial Infection; Viral Infection; Oral Infection

Treatments: Other: Lumineux Oral Essentials rinse; Other: Listerine rinse

Study type: Interventional

Funder types: Other

Identifiers

NCT05603650

20205719

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 3 patient groups, including a placebo group

Water rinse

Placebo Comparator group

Description:

rinse twice daily for 1 min with water

Treatment:

Other: Listerine rinse

Other: Lumineux Oral Essentials rinse

Lumineux Oral Essentials rinse

Experimental group

Description:

rinse twice daily for 1 min with Lumineux Oral Essentials rinse

Treatment:

Other: Listerine rinse

Listerine rinse

Experimental group

Description:

rinse twice daily for 1 min with Listerine rinse

Treatment:

Other: Lumineux Oral Essentials rinse