Antibacterial Mouthwash for Pharyngeal Gonorrhea Prevention

NCT04966507 | Completed Phase 2 Results 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 (6)

• Mouthwash Adherence - Percent of Days Mouthwash Used

  This outcome was assessed using self-reported questionnaire data asking participants to report "In the past 3 months, what proportion of days did you use the mouthwash?"

  This outcome will be measured over each 12-week intervention period

• Mouthwash Acceptability - Number of Participants Who Reported it Was Hard to Gargle/Rinse With Mouthwash

  This outcome will be assessed using self-reported questionnaire and is intended to measure acceptability of mouthwash as prevention strategy for pharyngeal gonnorrhea. Participants were asked "Did you experience any of the following difficulties using the mouthwash?" with answer choices including: It was hard to gargle/rinse I didn't like the mouthwash flavor/taste It was uncomfortable Amount of liquid was too much Amount of gargling time was too long

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

• Mouthwash Acceptability - Number of Participants Who Did Not Like Mouthwash Flavor/Taste

  This outcome will be assessed using self-reported questionnaire and is intended to measure acceptability of mouthwash as prevention strategy for pharyngeal gonnorrhea. Participants were asked "Did you experience any of the following difficulties using the mouthwash?" with answer choices including: It was hard to gargle/rinse I didn't like the mouthwash flavor/taste It was uncomfortable Amount of liquid was too much Amount of gargling time was too long

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

• Mouthwash Acceptability - Number of Participants Who Said Mouthwash Use Was Uncomfortable

  This outcome will be assessed using self-reported questionnaire and is intended to measure acceptability of mouthwash as prevention strategy for pharyngeal gonnorrhea. Participants were asked "Did you experience any of the following difficulties using the mouthwash?" with answer choices including: It was hard to gargle/rinse I didn't like the mouthwash flavor/taste It was uncomfortable Amount of liquid was too much Amount of gargling time was too long

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

• Mouthwash Acceptability - Number of Participants Who Said Amount of Liquid Was Too Much

  This outcome will be assessed using self-reported questionnaire and is intended to measure acceptability of mouthwash as prevention strategy for pharyngeal gonnorrhea. Participants were asked "Did you experience any of the following difficulties using the mouthwash?" with answer choices including: It was hard to gargle/rinse I didn't like the mouthwash flavor/taste It was uncomfortable Amount of liquid was too much Amount of gargling time was too long

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

• Mouthwash Acceptability - Number of Participants Who Said Gargling Time Was Too Long

  This outcome will be assessed using self-reported questionnaire and is intended to measure acceptability of mouthwash as prevention strategy for pharyngeal gonnorrhea. Participants were asked "Did you experience any of the following difficulties using the mouthwash?" with answer choices including: It was hard to gargle/rinse I didn't like the mouthwash flavor/taste It was uncomfortable Amount of liquid was too much Amount of gargling time was too long

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

Secondary Outcomes (1)

• Pharyngeal Gonorrhea - Laboratory Testing Results

  Past 12 weeks

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

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

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

Results Point of Contact

• Title: Dr. Marjan Javanbakht
• Organization: University of California Los Angeles

javan@ucla.edu

310-825-3234

Study Officials

• Marjan Javanbakht

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: July 9, 2026
• Results First Posted: July 9, 2026

Record last verified: 2026-06

Locations

US (1)