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

NCT ID: NCT05603650

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2027-12-31

Brief Summary

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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

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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

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Oral Bacterial Infection Oral Infection Microbial Colonization Viral Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators
White tape over receptacle

Study Groups

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Water rinse

rinse twice daily for 1 min with water

Group Type PLACEBO_COMPARATOR

Lumineux Oral Essentials rinse

Intervention Type OTHER

mouthrinse

Listerine rinse

Intervention Type OTHER

mouthrinse

Lumineux Oral Essentials rinse

rinse twice daily for 1 min with Lumineux Oral Essentials rinse

Group Type EXPERIMENTAL

Listerine rinse

Intervention Type OTHER

mouthrinse

Listerine rinse

rinse twice daily for 1 min with Listerine rinse

Group Type EXPERIMENTAL

Lumineux Oral Essentials rinse

Intervention Type OTHER

mouthrinse

Interventions

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Lumineux Oral Essentials rinse

mouthrinse

Intervention Type OTHER

Listerine rinse

mouthrinse

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, Irvine

OTHER

Sponsor Role lead

Responsible Party

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Petra E. Wilder-Smith

Professor of Surgery and Director of Dentistry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Petra Wilder-Smith, DDS, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Calfornia Irvine

Locations

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Beckman Laser Institute and Medical Clinic

Irvine, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Nicole Wakida, PhD

Role: CONTACT

[email protected]
949-824-4360

Facility Contacts

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Nicole Wakida, PhD

Role: primary

[email protected]
949-824-4360

Other Identifiers

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20205719

Identifier Type: -

Identifier Source: org_study_id