Summary

Eligibility
for people ages 18 years and up (full criteria)
Healthy Volunteers
healthy people welcome
Location
at Irvine, California
Dates
study started
completion around
Principal Investigator
by Petra E. Wilder-Smith

Description

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.

Details

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.

Keywords

Oral Bacterial Infection, Oral Infection, Microbial Colonization, Viral Infection, Oral Microbiome, Fecal Microbiome, Infections, Communicable Diseases, Bacterial Infections, Virus Diseases, Listerine, Lumineux Oral Essentials rinse, Listerine rinse, Water rinse

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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.

Location

  • Beckman Laser Institute and Medical Clinic accepting new patients
    Irvine California 92612 United States

Lead Scientist at UC Irvine

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Irvine
ID
NCT05603650
Study Type
Interventional
Participants
Expecting 200 study participants
Last Updated