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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether daily use of an antibacterial mouthwash can reduce throat gonorrhea cases, particularly in men who are HIV-positive or at high risk of HIV. It compares a regular mouthwash with an antibacterial one (Biotene Mouthwash) to determine if the latter effectively lowers infection rates. Men in the mSTUDY who have previously had throat gonorrhea may be suitable candidates. Participants must be willing to use the mouthwash daily and attend follow-up visits. Those unable to use mouthwash due to allergies or alcohol recovery are not eligible. As a Phase 2 trial, this research measures the treatment's effectiveness in a smaller group, allowing participants to contribute to significant medical advancements.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Listerine Cool Mint Antiseptic Mouthwash is generally safe and well-tolerated. This mouthwash is a popular choice in the U.S. for killing germs and freshening breath. Regular use has not led to major safety issues, making it a familiar option for many.

While no clear evidence supports its effectiveness in preventing sexually transmitted infections (STIs), it remains safe for oral use. Using Listerine as directed should not cause significant side effects for most people.

For those considering joining a clinical trial to test this mouthwash for preventing throat gonorrhea, it is reassuring to know that it is already widely used without major safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for gonorrhea?

Most treatments for preventing gonorrhea focus on antibiotics, which are aimed at treating the infection after it's been contracted. However, this trial explores a preventive approach using antibacterial mouthwash. Listerine Cool Mint Antiseptic Mouthwash is exciting because it uses a topical antiseptic method to potentially prevent the bacteria from taking hold in the throat, which is a common site for gonorrhea infections. This could offer a simple, non-invasive way to reduce transmission, unlike traditional systemic antibiotics. Researchers are particularly interested in whether this approach could help curb rising antibiotic resistance by reducing the need for antibiotic use.

What evidence suggests that this mouthwash is effective for preventing gonorrhea?

Research suggests that Listerine Cool Mint Antiseptic Mouthwash, tested in this trial, might help reduce throat gonorrhea. One study found that only 52% of men tested positive for gonorrhea after using Listerine compared to before. Another study indicates that using Listerine daily could significantly lower the amount of gonorrhea bacteria in the throat. However, some studies have shown mixed results, so more research is needed to confirm its effectiveness. Overall, Listerine seems promising, but it is not a guaranteed solution yet. Participants in this trial will use either Listerine or a placebo mouthwash, Biotene Oral Rinse, to evaluate Listerine's effectiveness in preventing gonorrhea. ^{6 7 8 9 10}

Who Is on the Research Team?

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.

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?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9211398/

Inhibitory Activity of Antibacterial Mouthwashes and Antiseptic ... Our data demonstrate that antibacterial mouthwashes and antiseptics vary in their ability to inhibit the in vitro growth of N. gonorrhoeae and saliva may ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1473309920307040

Antiseptic mouthwash for gonorrhoea prevention (OMEGA) This trial found that among men with positive oropharyngeal N gonorrhoeae cultures, only 17 (52%) were positive 5 min after gargling with Listerine mouthwash ...

3. frontiersin.org frontiersin.org/journals/medicine/articles/10.3389/fmed.2022.952476/full

Non-conventional interventions to prevent gonorrhea or ... Two further RCTs examining the efficacy of daily use of Listerine mouthwash for gonorrhea prevention but the results are inconclusive (55, 56). Additionally, ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04966507

Antibacterial Mouthwash for Pharyngeal Gonorrhea ... This study aims to determine acceptability and preliminary efficacy of daily use of an antibacterial mouthwash as compared to a placebo mouthwash in ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/27998950/

a randomised controlled trial and an in vitro study Conclusions: This data suggest Listerine, significantly reduces the amount of N. gonorrhoeae on the pharyngeal surface. With daily use it may increase ...

6. listerine.com listerine.com/mouthwash/antiseptic/listerine-cool-mint-mouthwash

COOL MINT® Antiseptic Mouthwash for Bad Breath & ... The LISTERINE® COOL MINT® mouthwash is not only antimicrobial and a germ killer, but also a people pleaser. An oral antiseptic, it has been America's favorite ...

7. dentistry.ouhsc.edu dentistry.ouhsc.edu/Portals/1328/assets/Documents/Intranet/Listerine.pdf?ver=2022-11-08-133719-060

SAFETY DATA SHEET SAFETY DATA SHEET. 1. IDENTIFICATION. Product identifier. Product Name. Listerine Cool Mint Listerine. Specification No. PR-007326. Pure ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33676596/

Antibacterial mouthwash to prevent sexually transmitted ... In the Listerine-placebo group, the STI incidence rate was 140·4 per 100 person-years during the Listerine period, and 102·6 per 100 person-years during the ...

9. listerine.com listerine.com/mouthwash/antiseptic/listerine-cool-mint-mouthwash?utm_source=google&utm_medium=cpc&utm_campaign=GO-USA-ENG-PS-Listerine-BP-EX-RN-Mouthwash+Products&utm_content=Mouthwash+-+Cool+Mint&utm_term=listerine+cool+mint+mouthwash&gclid=CjwKCAjww5r8BRB6EiwArcckCzjlU02jNIrbzxdqTans-jPFhtgfq3GSaq1jVnLQ7c7Fg1bfqjsy1hoCSBkQAvD_BwE&gclsrc=aw.ds&utm_source=Audience+%28active+subscribed+patients%29+updated+7.14.20&utm_campaign=968eec6b41-EMAIL_CAMPAIGN_2019_09_25_07_04_COPY_01&utm_medium=email&utm_term=0_1c10fe2971-968eec6b41-71514535&bvstate=pg:2/ct:r

COOL MINT® Antiseptic Mouthwash for Bad Breath & Plaque The LISTERINE® COOL MINT® mouthwash is not only antimicrobial and a germ killer, but also a people pleaser. An oral antiseptic, it has been America's favorite ...

10. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1473309920307787

Antibacterial mouthwash to prevent sexually transmitted ... Our findings do not support the use of Listerine Cool Mint as a way to prevent STI acquisition among high-risk populations.