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

Last updated: January 14, 2025
Sponsor: University of California, Irvine
Overall Status: Active - Recruiting

Phase

N/A

Condition

Bacterial Infections

Treatment

Listerine rinse

Lumineux Oral Essentials rinse

Clinical Study ID

NCT05603650
20205719
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

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 opinionof the Principal Investigator may preclude the volunteer's ability to comply withstudy requirements, including completion of the study or the quality of the data.

Study Design

Total Participants: 200
Treatment Group(s): 2
Primary Treatment: Listerine rinse
Phase:
Study Start date:
September 01, 2021
Estimated Completion Date:
December 31, 2027

Study 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.

Connect with a study center

  • Beckman Laser Institute

    Irvine, California 92612
    United States

    Active - Recruiting

  • Beckman Laser Institute and Medical Clinic

    Irvine, California 92612
    United States

    Active - Recruiting

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