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Recruiting NCT05603650

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

No phase Interventional Oral Bacterial Infection Oral Infection Microbial Colonization Viral Infection

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Lumineux Oral Essentials rinse, Listerine rinse.
Who it may be relevant to
Registry conditions: Oral Bacterial Infection, Oral Infection, Microbial Colonization, Viral Infection. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Detailed 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.

Interventions

  • Other Lumineux Oral Essentials rinse
    mouthrinse
  • Other Listerine rinse
    mouthrinse

Primary outcome measures

  • total bacterial load and mRNA analysis [Time frame: Day 0]
  • total bacterial load and mRNA analysis [Time frame: Day 30]
  • total bacterial load and mRNA analysis [Time frame: Day 60]
  • total bacterial load and mRNA analysis [Time frame: Day 90]
  • total bacterial load and mRNA analysis [Time frame: Day 180]
  • viral load and mRNA analysis using RT-PCR [Time frame: Day 0]
  • viral load and mRNA analysis using RT-PCR [Time frame: Day 30]
  • viral load and mRNA analysis using RT-PCR [Time frame: Day 60]
  • viral load and mRNA analysis using RT-PCR [Time frame: Day 90]
  • viral load and mRNA analysis using RT-PCR [Time frame: Day 180]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Other

Study locations

United States · 1 center
  • Beckman Laser Institute and Medical Clinic — Irvine

Identifiers

NCT: NCT05603650 · 20205719

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗