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NCT Number: NCT05603650

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

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.

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Key information

Conditions

Oral Bacterial Infection Communicable Diseases Disease Attributes Infections Microbial Colonization Oral Infection Pathologic Processes Pathological Conditions, Signs and Symptoms Viral Infection Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beckman Laser Institute and Medical Clinic

Irvine, California, 92612, United States

Location status: Recruiting

Location contact

Nicole Wakida, PhD

CONTACT

[email protected]

949-824-4360

Petra Wilder-Smith, DDS, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lumineux Oral Essentials rinse

Other

mouthrinse

Listerine rinse

Other

mouthrinse

Primary outcomes

  1. total bacterial load and mRNA analysis

    Time frame: Day 0

    total bacterial load as determined from oral swabs and collected fecal samples, followed by subsequent standard mRNA analysis using RT-PCR

  2. total bacterial load and mRNA analysis

    Time frame: Day 30

    total bacterial load as determined from oral swabs and collected fecal samples, followed by subsequent standard mRNA analysis using RT-PCR

  3. total bacterial load and mRNA analysis

    Time frame: Day 60

    total bacterial load as determined from oral swabs and collected fecal samples, followed by subsequent standard mRNA analysis using RT-PCR

  4. total bacterial load and mRNA analysis

    Time frame: Day 90

    total bacterial load as determined from oral swabs and collected fecal samples, followed by subsequent standard mRNA analysis using RT-PCR

  5. total bacterial load and mRNA analysis

    Time frame: Day 180

    total bacterial load as determined from oral swabs and collected fecal samples, followed by subsequent standard mRNA analysis using RT-PCR

  6. viral load and mRNA analysis using RT-PCR

    Time frame: Day 0

    viral load: HSV1, CMV, EBV

  7. viral load and mRNA analysis using RT-PCR

    Time frame: Day 30

    viral load: HSV1, CMV, EBV

  8. viral load and mRNA analysis using RT-PCR

    Time frame: Day 60

    viral load: HSV1, CMV, EBV

  9. viral load and mRNA analysis using RT-PCR

    Time frame: Day 90

    viral load: HSV1, CMV, EBV

  10. viral load and mRNA analysis using RT-PCR

    Time frame: Day 180

    viral load: HSV1, CMV, EBV

Study contacts

Contact information is provided by the study sponsor or research team.

Nicole Wakida, PhD

CONTACT

[email protected]

949-824-4360

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Registry information

Official study title

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

Acronym: Microbiome

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Nov 3, 2022
Registry last updated
Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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