Effects of Mouthrinse on the Microbiome of the Oral Cavity and GI Tract
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, Irvine
About this trial
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
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Lumineux Oral Essentials rinse
Other interventionmouthrinse
Listerine rinse
Other interventionmouthrinse
Treatment groups
200 Participants
are divided into 3 treatment groupsGroup A: Water rinsePlacebo comparator 2 interventions
Group B: Lumineux Oral Essentials rinseExperimental treatment 1 intervention
Group C: Listerine rinseExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
Day 02
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
Time frame
Day 303
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
Time frame
Day 604
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
Time frame
Day 90Sponsors and contacts
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Source ClinicalTrials.gov