Effects of mouthrinse on oral and gut bacteria and viruses
Effects of Mouthrinses on the Microbiome of the Oral Cavity and GI Tract
This study is testing how two popular mouthwashes affect the bacteria and viruses in your mouth and gut over six months.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, Irvine Academic / other |
| Locations | 1 site (Irvine, California) |
| Trial ID | NCT05603650 on ClinicalTrials.gov |
What this trial studies
This research investigates how two over-the-counter mouthwashes, Listerine and Lumineux Oral Essentials, affect the microbiome in the mouth and gastrointestinal tract. Participants will be randomly assigned to rinse with one of the mouthwashes or water twice daily for 180 days. The study includes five visits where oral plaque and fecal samples will be collected to analyze changes in microbial populations. The goal is to understand the impact of these mouthwashes on oral and gut health.
Who should consider this trial
Good fit: Ideal candidates are healthy men and non-pregnant, non-lactating women aged 18-25 with healthy gums.
Not a fit: Patients with fewer than 20 teeth or those who have taken antibiotics in the last three months may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved oral and gastrointestinal health through better understanding of microbiome management.
How similar studies have performed: While studies on oral microbiome interventions exist, this specific approach using these mouthwashes is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Irvine, California
- Beckman Laser Institute and Medical Clinic — Irvine, California, United States (Recruiting)
Study contacts
- Principal investigator: Petra Wilder-Smith, DDS, PhD — University of Calfornia Irvine
- Study coordinator: Nicole Wakida, PhD
- Email: nwakida@uci.edu
- Phone: 949-824-4360
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.