NCT05603650 Effects of Mouthrinse on the Microbiome of the Oral Cavity and GI Tract
| NCT ID | NCT05603650 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, Irvine |
| Condition | Oral Bacterial Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2021-09-01 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2021-09-01 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Petra Wilder-Smith, DDS, PhD
PRINCIPAL INVESTIGATOR
University of Calfornia Irvine
Frequently Asked Questions
Who can join the NCT05603650 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Oral Bacterial Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05603650 currently recruiting?
Yes, NCT05603650 is actively recruiting participants. Contact the research team at nwakida@uci.edu for enrollment information.
Where is the NCT05603650 trial being conducted?
This trial is being conducted at Irvine, United States.
Who is sponsoring the NCT05603650 clinical trial?
NCT05603650 is sponsored by University of California, Irvine. The principal investigator is Petra Wilder-Smith, DDS, PhD at University of Calfornia Irvine. The trial plans to enroll 200 participants.