Antibacterial Mouthwash for Gonorrhea Prevention

Overseen By Risa Flynn, PhD

Age: 18 - 65

Sex: Male

Trial Phase: Phase 2

Sponsor: University of California, Los Angeles

Disqualifiers: Mouthwash allergies, Alcohol recovery, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

100 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you will need to stop using your current mouthwash during the 24-week study period.

What data supports the effectiveness of the treatment Biotene Mouthwash, Listerine Antiseptic Mouthwash Product for preventing gonorrhea?

Research shows that Listerine mouthwash has been found to kill the bacteria that cause gonorrhea in laboratory settings, and a recent trial suggested that using mouthwash might help reduce the risk of getting oropharyngeal gonorrhea, especially among men who have sex with men. ^{1 2 3 4 5}

Is antibacterial mouthwash safe for humans?

Biotene and Listerine mouthwashes have been used safely in various studies, including for conditions like dry mouth and oral discomfort in cancer patients, showing improvements in symptoms without major safety concerns. ^{1 2 6 7 8}

How does Biotene Mouthwash differ from other treatments for gonorrhea prevention?

Biotene Mouthwash is unique because it is being studied as a preventive treatment for gonorrhea, specifically targeting the throat area, which is not a standard approach for this condition. Unlike traditional antibiotic treatments, it is a non-drug option that may help reduce the risk of infection through regular oral hygiene practices. ^{1 2 5 9 10}

Research Team

Marjan Javanbakht

Principal Investigator

University of California, Los Angeles

Eligibility Criteria

This trial is for HIV-positive and high-risk HIV-negative men who have had unprotected anal intercourse in the past 6 months. Participants must be willing to attend follow-up visits, provide consent, and share contact information. They should be aged 18-45, biologically male at birth, and previously diagnosed with pharyngeal gonorrhea.

Inclusion Criteria

Understands and agrees to local STI reporting requirements

Currently enrolled in mSTUDY

I can attend follow-up visits every 6 months for the study duration.

Exclusion Criteria

You cannot use mouthwash, especially if you are allergic to it or if you are avoiding alcohol because you are a recovering alcoholic.

I will not stop using my current mouthwash for 6 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment Phase 1

Participants receive either antibacterial mouthwash or placebo for 12 weeks

12 weeks

1 visit (in-person) at baseline

Treatment Phase 2

Participants crossover to the alternate mouthwash (antibacterial or placebo) for another 12 weeks

12 weeks

1 visit (in-person) at 12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

1 visit (in-person) at 24 weeks

Treatment Details

Interventions

• Biotene Mouthwash
• Listerine Antiseptic Mouthwash Product

Trial Overview The study compares daily use of Listerine Antiseptic Mouthwash against Biotene (placebo) to prevent pharyngeal gonorrhea in men. It aims to assess adherence, satisfaction with mouthwash use, and whether antibacterial mouthwash reduces infection incidence more effectively than placebo.

Participant Groups

Group I: Listerine Cool Mint Antiseptic Mouthwash Active Control 1 Intervention

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

Group II: Biotene Oral Rinse Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Trials

3,361

Recruited

5,516,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Antiseptic mouthwash for gonorrhoea prevention (OMEGA): a randomised, double-blind, parallel-group, multicentre trial. [2021]

2. England pubmed.ncbi.nlm.nih.gov

The development of mouthwashes without anti-gonococcal activity for controlled clinical trials: an in vitro study. [2020]

3. Australia pubmed.ncbi.nlm.nih.gov

Translating mouthwash use for gonorrhoea prevention into a public health campaign: identifying current knowledge and research gaps. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Inhibitory Activity of Antibacterial Mouthwashes and Antiseptic Substances against Neisseria gonorrhoeae. [2022]

5. England pubmed.ncbi.nlm.nih.gov

A multicentre double-blind randomised controlled trial evaluating the efficacy of daily use of antibacterial mouthwash against oropharyngeal gonorrhoea among men who have sex with men: the OMEGA (Oral Mouthwash use to Eradicate GonorrhoeA) study protocol. [2019]

6. Germany pubmed.ncbi.nlm.nih.gov

Efficacy of GUM® Hydral versus Biotène® Oralbalance mouthwashes plus gels on symptoms of medication-induced xerostomia: a randomized, double-blind, crossover study. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

A phase II study of Biotene in the treatment of postradiation xerostomia in patients with head and neck cancer. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Controlled study of lactoperoxidase gel on oral flora and saliva in irradiated patients with oral cancer. [2010]

9. Australia pubmed.ncbi.nlm.nih.gov

Adherence to, and acceptability of, Listerine® mouthwash as a potential preventive intervention for pharyngeal gonorrhoea among men who have sex with men in Australia: a longitudinal study. [2018]

10. England pubmed.ncbi.nlm.nih.gov

Antiseptic mouthwash against pharyngeal Neisseria gonorrhoeae: a randomised controlled trial and an in vitro study. [2020]