Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID05603650

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

Led by University of California, Irvine · Updated on 2025-12-17

200

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research evaluates the effects of two over-the-counter mouthwashes on bacteria and viruses in the mouth and gut. The study aims to understand how these mouthwashes impact the microbiome of the oral cavity and gastrointestinal tract. Participants include healthy adults, and the study is designed as a pilot to compare antimicrobial and microbial product-targeting mouthrinses along with a water rinse control group. Participants will be randomly assigned to rinse their mouth twice daily for one minute with either Listerine mouthwash, Lumineux Oral Essentials mouthwash, or water for about 180 days. Oral plaque samples will be collected on study days 0, 30, 60, 90, and 180 using a sterile swab kit. Some participants will also provide fecal samples for analysis. Throughout the study, participants will attend approximately five visits lasting 15 to 30 minutes each, totaling around 2.5 hours. Researchers will analyze total bacterial load and viral load with mRNA analysis at each visit using RT-PCR methods. Follow-up may include telephone contact, and the study monitors changes in oral and gut microbiomes over time to assess the effects of the mouthrinses.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Eligible men and non-pregnant and non-lactating women aged 18 to 25 years
  • Volunteers must consent to participate in all scheduled exam visits and procedures
  • Volunteers must be available for follow-up by telephone
  • Healthy gums or gums that bleed when brushing
Not Eligible

You will not qualify if you...

  • Volunteers unable or unwilling to sign the informed consent form
  • Having less than 20 teeth, excluding third molars
  • Use of antibiotics within the previous 3 months
  • Any condition or situation that may prevent compliance with study requirements or completion of the study as judged by the Principal Investigator

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Approximately 180 days

Participants rinse twice daily for 1 minute with either water, Lumineux Oral Essentials rinse, or Listerine rinse for approximately 180 days.

5 visits (Days 0, 30, 60, 90, and 180) for oral plaque and some fecal sample collection

Trial Site Locations

Total: 1 location

1

Beckman Laser Institute and Medical Clinic

Irvine, California, United States, 92612

Actively Recruiting

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Research Team

N

Nicole Wakida, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

3

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