RECRUITING

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

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Conditions

Oral Bacterial InfectionOral InfectionMicrobial ColonizationViral InfectionOral MicrobiomeFecal Microbiome

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-09-01
Study Completion:2027-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05603650

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Eligible men and non-pregnant and non-lactating women of all races age 18-25.
  2. * Volunteers must consent to participate in all scheduled exam visits and procedures.
  3. * Volunteers must be available for follow up on the telephone.
  4. * Healthy gums or gums that bleed when you brush them.
  1. * Volunteers unable or unwilling to sign the informed consent form.
  2. * Less than 20 teeth (excluding third molars).
  3. * Individuals who have taken antibiotics in the previous 3 months.
  4. * 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.

Contacts and Locations

Study Contact

Nicole Wakida, PhD
CONTACT
949-824-4360
nwakida@uci.edu

Principal Investigator

Petra Wilder-Smith, DDS, PhD
PRINCIPAL_INVESTIGATOR
University of Calfornia Irvine

Study Locations (Sites)

Beckman Laser Institute and Medical Clinic
Irvine, California, 92612
United States

Collaborators and Investigators

Sponsor: University of California, Irvine

  • Petra Wilder-Smith, DDS, PhD, PRINCIPAL_INVESTIGATOR, University of Calfornia Irvine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-09-01
Study Completion Date2027-12

Study Record Updates

Study Start Date2021-09-01
Study Completion Date2027-12

Terms related to this study

Keywords Provided by Researchers

  • Oral Microbiome
  • Fecal Microbiome

Additional Relevant MeSH Terms

  • Oral Bacterial Infection
  • Oral Infection
  • Microbial Colonization
  • Viral Infection