Antibacterial Mouthwash for Pharyngeal Gonorrhea Prevention

NCT04966507 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: R21AI147969
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

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. 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. 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.

Conditions

Gonorrhea

Outcome Measures

Primary Outcomes (4)

• Adherence and acceptability of mouthwash use

  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.

  This outcome will be measured at 12-weeks post intervention.

• Adherence and acceptability of mouthwash use

  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.

  This outcome will be measured at 24-weeks post intervention.

• Laboratory identified pharyngeal gonorrhea

  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.

  This outcome will be measured at 12-weeks post intervention.

• Laboratory identified pharyngeal gonorrhea

  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.

  This outcome will be measured at 24-weeks post intervention.

Study Arms (2)

Listerine Cool Mint Antiseptic Mouthwash

ACTIVE COMPARATOR

Daily use of an antibacterial mouthwash (Listerine Cool Mint Antiseptic Mouthwash) during the 12-week follow-up period.

Drug: Listerine Antiseptic Mouthwash Product

Biotene Oral Rinse

PLACEBO COMPARATOR

Daily use of a placebo mouthwash with no known antibacterial qualities (Biotene Oral Rinse) during the 12-week follow-up period.

Drug: Biotene Mouthwash

Interventions

Listerine Antiseptic Mouthwash Product DRUG

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.

Also known as: Active Mouthwash

Listerine Cool Mint Antiseptic Mouthwash

Biotene Mouthwash DRUG

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.

Also known as: Placebo Mouthwash

Biotene Oral Rinse

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• At least 18 but not older than 45 years of age on day of consent
• Identified biologically male at birth
• 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
• Willing and able to provide written informed consent to take part in the study
• Willing and able to provide adequate information for locator purposes
• STI testing at each study visit (with reporting and treatment referral when indicated)
• Understands and agrees to local STI reporting requirements
• If HIV-negative at screening, report unprotected anal intercourse with a male in the past 6 months
• Currently enrolled in mSTUDY
• Previously diagnosed with pharyngeal gonorrhea (while an mSTUDY participant)
• Participants will be excluded from the study if:
• 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
• They are unwilling to stop use of their current mouthwash during the 24-week study period

Sponsors & Collaborators

• University of California, Los Angeles: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Los Angeles LGBT Center

Los Angeles, California, 90028, United States

Location

MeSH Terms

Conditions

Gonorrhea

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sexually Transmitted Diseases, Bacterial; Sexually Transmitted Diseases; Communicable Diseases; Genital Diseases; Urogenital Diseases

Study Officials

• Marjan Javanbakht

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 26, 2021
• First Posted: July 19, 2021
• Study Start: February 17, 2022
• Primary Completion: May 16, 2025
• Study Completion: December 12, 2025
• Last Updated: February 13, 2026

Record last verified: 2026-02

Locations

US (1)