100 Participants Needed

Antibacterial Mouthwash for Gonorrhea Prevention

MJ
RF
Overseen ByRisa Flynn, PhD
Age: 18 - 65
Sex: Male
Trial Phase: Phase 2
Sponsor: University of California, Los Angeles
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

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.

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.12345

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.12678

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.127910

Who Is on the Research Team?

MJ

Marjan Javanbakht

Principal Investigator

University of California, Los Angeles

Are You a Good Fit for This Trial?

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.
See 9 more

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Active Control
Placebo Group
Group I: Listerine Cool Mint Antiseptic MouthwashActive Control1 Intervention
Group II: Biotene Oral RinsePlacebo Group1 Intervention

Find a Clinic Near You

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+

Citations

Antiseptic mouthwash for gonorrhoea prevention (OMEGA): a randomised, double-blind, parallel-group, multicentre trial. [2021]
The development of mouthwashes without anti-gonococcal activity for controlled clinical trials: an in vitro study. [2020]
Translating mouthwash use for gonorrhoea prevention into a public health campaign: identifying current knowledge and research gaps. [2020]
Inhibitory Activity of Antibacterial Mouthwashes and Antiseptic Substances against Neisseria gonorrhoeae. [2022]
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]
Efficacy of GUM® Hydral versus Biotène® Oralbalance mouthwashes plus gels on symptoms of medication-induced xerostomia: a randomized, double-blind, crossover study. [2022]
A phase II study of Biotene in the treatment of postradiation xerostomia in patients with head and neck cancer. [2019]
Controlled study of lactoperoxidase gel on oral flora and saliva in irradiated patients with oral cancer. [2010]
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]
Antiseptic mouthwash against pharyngeal Neisseria gonorrhoeae: a randomised controlled trial and an in vitro study. [2020]
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