Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05603650
Other study ID # 20205719
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 1, 2021
Est. completion date December 2027

Study information

Verified date April 2024
Source University of California, Irvine
Contact Nicole Wakida, PhD
Phone 949-824-4360
Email nwakida@uci.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date December 2027
Est. primary completion date December 2027
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

Other:
Lumineux Oral Essentials rinse
mouthrinse
Listerine rinse
mouthrinse

Locations

Country Name City State
United States Beckman Laser Institute and Medical Clinic Irvine California

Sponsors (1)

Lead Sponsor Collaborator
University of California, Irvine

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary total bacterial load and mRNA analysis total bacterial load as determined from oral swabs and collected fecal samples, followed by subsequent standard mRNA analysis using RT-PCR Day 0
Primary total bacterial load and mRNA analysis total bacterial load as determined from oral swabs and collected fecal samples, followed by subsequent standard mRNA analysis using RT-PCR Day 30
Primary total bacterial load and mRNA analysis total bacterial load as determined from oral swabs and collected fecal samples, followed by subsequent standard mRNA analysis using RT-PCR Day 60
Primary total bacterial load and mRNA analysis total bacterial load as determined from oral swabs and collected fecal samples, followed by subsequent standard mRNA analysis using RT-PCR Day 90
Primary total bacterial load and mRNA analysis total bacterial load as determined from oral swabs and collected fecal samples, followed by subsequent standard mRNA analysis using RT-PCR Day 180
Primary viral load and mRNA analysis using RT-PCR viral load: HSV1, CMV, EBV Day 0
Primary viral load and mRNA analysis using RT-PCR viral load: HSV1, CMV, EBV Day 30
Primary viral load and mRNA analysis using RT-PCR viral load: HSV1, CMV, EBV Day 60
Primary viral load and mRNA analysis using RT-PCR viral load: HSV1, CMV, EBV Day 90
Primary viral load and mRNA analysis using RT-PCR viral load: HSV1, CMV, EBV Day 180
See also
  Status Clinical Trial Phase
Recruiting NCT05414994 - Assessment of the Ocular Microbiome in Health and Disease
Completed NCT04769882 - Er:YAG Laser Effects on Microbial Population in Conservative Dentistry N/A
Completed NCT04766528 - Effect of Diet on the Microbiota / Endoccanabinoidome Axis in Response to Physical Activity N/A
Completed NCT03720314 - Microbiota Profiling in IBS
Completed NCT04122612 - Shaping Microbiome in the First 1,000 Days of Life
Not yet recruiting NCT05405634 - Microbiota in Chronic Anal Fissure and Its Association With Prognosis
Not yet recruiting NCT04895774 - Ex Vivo Study of the Mechanism of Action of Active Ingredients on the Intestinal Microbiota
Recruiting NCT05992688 - The Sweet Kids Study (Stevia on Weight and Energy Effect Over Time) N/A
Recruiting NCT05502380 - Broad-spectrum Antibiotic Prophylaxis in Tumor and Infected Orthopedic Surgery Phase 3
Completed NCT05175833 - Oral Probiotics and Secondary Bacterial Pneumonia in Severe COVID-19 Phase 2
Recruiting NCT04836910 - Microbiome and Polycystic Ovaries
Completed NCT04991818 - MSC - OneBiome UX Pilot Study N/A
Completed NCT05575050 - Impact of Teeth Brushing in Ventilated COVID-19 Patients. N/A
Completed NCT04374955 - The Effect of Probiotic Added to Maternal Diet on Infantile Colic and Intestinal Microbiota Content N/A
Recruiting NCT04140747 - Transfer of Strictly Anaerobe Microbes From Mother to Child
Recruiting NCT04111471 - The Use of A Prebiotic to Promote a Healthy Gut Microbiome in Pediatric Stem Cell Transplant Recipients N/A
Suspended NCT03220282 - The Milk, Growth and Microbiota Study N/A
Completed NCT03422562 - Probiotics and Intestinal Microbiome in Preterm Infants Phase 3
Recruiting NCT05695196 - Feasibility and Safety Study of Parent-to-Child Nasal Microbiota Transplant Phase 1
Completed NCT04223375 - Effect of Nutrition Training on Mothers' Nutrition Pattern, Breast Milk and Newborn Intestinal Microbiota N/A