Mouthrinse Effects on Oral and Gut Microbiome

This study is looking at how two common mouthwashes, Lumineux Oral Essentials rinse and Listerine rinse, affect the bacteria and three viruses in your mouth and gut. You would be randomly assigned to use one of these mouthwashes or water twice a day. Researchers will measure the total amount of bacteria and genetic material (mRNA) in your mouth at the start, and again at 30 and 60 days to see the effects. We are looking for healthy individuals aged 18-25, who are not pregnant or breastfeeding, and have healthy gums or gums that bleed when brushed. The study aims to enroll 200 participants, but its current status is unclear.

Study design
This interventional study plans to enroll 200 participants who will be randomly assigned to one of three groups: Lumineux Oral Essentials rinse, Listerine rinse, or water.
What's involved
You would rinse your mouth twice daily for about 180 days. This involves approximately 5 visits, each lasting 15-30 minutes, for a total of about 2.5 hours of your time. Oral plaque and, for some, fecal matter will be collected at various time points.
Compensation
Not stated in the trial record.
Follow-up
Researchers will collect samples and analyze them at Day 0, Day 30, and Day 60 to track changes in bacteria and mRNA.

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NCT05603650

Effects of Mouthrinse on the Microbiome of the Oral Cavity and GI Tract

Recruiting
NAAges 18+Interventional
University of California, Irvine
~200 participants
Updated 2025-12-17 on ClinicalTrials.gov
What's tested:Lumineux Oral Essentials rinseListerine rinse

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
total bacterial load and mRNA analysis
Measured over Day 0
+9 more outcomes measured
Oral Bacterial Infection
Oral Infection
Microbial Colonization
Viral Infection
1 sites across 1 states
California1
  • Petra Wilder-Smith, DDS, PhD · PRINCIPAL_INVESTIGATOR · University of Calfornia Irvine

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Eligibility criteria

Inclusion

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

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.
  • total bacterial load and mRNA analysisDay 0

    total bacterial load as determined from oral swabs and collected fecal samples, followed by subsequent standard mRNA analysis using RT-PCR

  • total bacterial load and mRNA analysisDay 30

    total bacterial load as determined from oral swabs and collected fecal samples, followed by subsequent standard mRNA analysis using RT-PCR

  • total bacterial load and mRNA analysisDay 60

    total bacterial load as determined from oral swabs and collected fecal samples, followed by subsequent standard mRNA analysis using RT-PCR

  • total bacterial load and mRNA analysisDay 90

    total bacterial load as determined from oral swabs and collected fecal samples, followed by subsequent standard mRNA analysis using RT-PCR

  • total bacterial load and mRNA analysisDay 180

    total bacterial load as determined from oral swabs and collected fecal samples, followed by subsequent standard mRNA analysis using RT-PCR

  • viral load and mRNA analysis using RT-PCRDay 0

    viral load: HSV1, CMV, EBV

  • viral load and mRNA analysis using RT-PCRDay 30

    viral load: HSV1, CMV, EBV

  • viral load and mRNA analysis using RT-PCRDay 60

    viral load: HSV1, CMV, EBV

  • viral load and mRNA analysis using RT-PCRDay 90

    viral load: HSV1, CMV, EBV

  • viral load and mRNA analysis using RT-PCRDay 180

    viral load: HSV1, CMV, EBV