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Antibacterial Mouthwash for Pharyngeal Gonorrhea Prevention

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ClinicalTrials.gov Identifier: NCT04966507
Recruitment Status : Recruiting
First Posted : July 19, 2021
Last Update Posted : June 3, 2022
Sponsor:
Information provided by (Responsible Party):
Marjan Javanbakht, MPH, PhD, University of California, Los Angeles

Brief Summary:

This study aims to determine acceptability and preliminary efficacy of daily use of an antibacterial mouthwash as compared to a placebo mouthwash in reducing the incidence of pharyngeal gonorrhea among a cohort of HIV-positive and high risk HIV-negative men.

Investigators plan to test the following hypotheses:

  1. Participants will maintain a high level of adherence and satisfaction with daily mouthwash use. Furthermore, the investigators hypothesize that barriers to adherence will include structural factors such as unstable housing and individual level factors such as substance use.
  2. Participants receiving the antibacterial mouthwash will have a lower incidence of pharyngeal gonorrhea as compared to participants receiving the placebo mouthwash. Furthermore, the investigators hypothesize that these reductions will remain even after adjusting for other factors such as HIV-status and substance use.

Condition or disease Intervention/treatment Phase
Gonorrhea Drug: Listerine Antiseptic Mouthwash Product Drug: Biotene Mouthwash Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized Crossover Study to Evaluate the Efficacy of Antibacterial Mouthwash in Preventing Pharyngeal Gonorrhea Among a High Risk Population
Actual Study Start Date : February 17, 2022
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Listerine Cool Mint Antiseptic Mouthwash
Daily use of an antibacterial mouthwash (Listerine Cool Mint Antiseptic Mouthwash) during the 12-week follow-up period.
Drug: Listerine Antiseptic Mouthwash Product
COOL MINT LISTERINE® Antiseptic Mouthwash will be used as the 'active' study drug condition. This is a commercially available, over the counter mouthwash product. Active ingredients for this product include Eucalyptol 0.092%, Menthol 0.042%, Methyl salicylate 0.060%, Thymol 0.064%. This product also contains 21% alcohol. Participants will be asked to rinse and gargle their mouth with 20mL of mouthwash daily.
Other Name: Active Mouthwash

Placebo Comparator: Biotene Oral Rinse
Daily use of a placebo mouthwash with no known antibacterial qualities (Biotene Oral Rinse) during the 12-week follow-up period.
Drug: Biotene Mouthwash
Biotène Rinse is designed with a moisturizing formula to help relieve dry mouth symptoms and is specifically designed to have a pH similar to saliva. This is a commercially available, over the counter mouthwash product. Biotène Mouthwash Ingredients include: Purified Water, Propylene Glycol, Hydrogenated Starch Hydrolysate, Poloxamer 407, Hydroxyethylcellulose, Sodium Benzoate, Flavor (Peppermint Oil), Benzoic Acid, Disodium Phosphate, Zinc Gluconate, Lactoferrin, Lysozyme, Lactoperoxidase, Potassium Thiocyanate, Aloe Vera Gel, Calcium Lactate, Glucose Oxidase. Participants will be asked to rinse and gargle their mouth with 20mL of mouthwash daily.
Other Name: Placebo Mouthwash




Primary Outcome Measures :
  1. Adherence and acceptability of mouthwash use [ Time Frame: This outcome will be measured at 12-weeks post intervention. ]
    This outcome will be assessed using self-reported questionnaire data and will include mouthwash use in terms of number of days used, amount of mouthwash used, number of times per day, duration of gargling/rinsing; reasons for not using mouthwash, and overall experience.

  2. Adherence and acceptability of mouthwash use [ Time Frame: This outcome will be measured at 24-weeks post intervention. ]
    This outcome will be assessed using self-reported questionnaire data and will include mouthwash use in terms of number of days used, amount of mouthwash used, number of times per day, duration of gargling/rinsing; reasons for not using mouthwash, and overall experience.

  3. Laboratory identified pharyngeal gonorrhea [ Time Frame: This outcome will be measured at 12-weeks post intervention. ]
    Pharyngeal swabs will be collected for gonorrhea testing using Nucleic acid amplification testing (NAAT) with Aptima Combo 2 (GenProbe, San Diego, CA). Additionally, all participants will be asked to provide consent to access medical records in order to verify any pharyngeal gonorrhea diagnoses made during the study period but resulting from testing conducted outside of the study.

  4. Laboratory identified pharyngeal gonorrhea [ Time Frame: This outcome will be measured at 24-weeks post intervention. ]
    Pharyngeal swabs will be collected for gonorrhea testing using Nucleic acid amplification testing (NAAT) with Aptima Combo 2 (GenProbe, San Diego, CA). Additionally, all participants will be asked to provide consent to access medical records in order to verify any pharyngeal gonorrhea diagnoses made during the study period but resulting from testing conducted outside of the study.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

This study will only include participants recruited as part an NIH/NIDA funded study (U01 DA036267 PIs Gorbach and Shoptaw) - the mSTUDY. By design, half of the participants are HIV-positive and half are HIV-negative and other inclusion criteria for the mSTUDY are as follows:

  1. At least 18 but not older than 45 years of age on day of consent
  2. Identified biologically male at birth
  3. Willing to return for follow-up study visits every 6 months as long as the study is ongoing and be available to return for all study visits, barring unforeseen circumstances
  4. Willing and able to provide written informed consent to take part in the study
  5. Willing and able to provide adequate information for locator purposes
  6. STI testing at each study visit (with reporting and treatment referral when indicated)
  7. Understands and agrees to local STI reporting requirements
  8. If HIV-negative at screening, report unprotected anal intercourse with a male in the past 6 months

    Additional inclusion criteria specific to this study are:

  9. Currently enrolled in mSTUDY
  10. mSTUDY participants who have turned 45 since enrollment in mSTUDY continue to be eligible for inclusion in this study.
  11. Previously diagnosed with pharyngeal gonorrhea (while an mSTUDY participant)

Participants will be excluded from the study if:

  1. Mouthwash use is contraindicated, for example because of allergies or those who may need to avoid the high alcohol content of mouthwash such as recovery alcoholics maintaining their sobriety
  2. They are unwilling to stop use of their current mouthwash during the 24-week study period

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04966507


Contacts
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Contact: Marjan Javanbakht, PhD 310-739-8107 javan@ucla.edu

Locations
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United States, California
Los Angeles LGBT Center Recruiting
Los Angeles, California, United States, 90028
Contact: Risa Flynn, PhD         
Sponsors and Collaborators
University of California, Los Angeles
Investigators
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Principal Investigator: Marjan Javanbakht University of California, Los Angeles
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Responsible Party: Marjan Javanbakht, MPH, PhD, Principal Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT04966507    
Other Study ID Numbers: R21AI147969 ( U.S. NIH Grant/Contract )
First Posted: July 19, 2021    Key Record Dates
Last Update Posted: June 3, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Gonorrhea
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Infections
Sexually Transmitted Diseases, Bacterial
Sexually Transmitted Diseases
Communicable Diseases
Listerine
Anti-Infective Agents, Local
Anti-Infective Agents