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Antibacterial Agent

Antibacterial Mouthwash for Gonorrhea Prevention

Phase 2
Recruiting
Led By Marjan Javanbakht
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
At least 18 but not older than 45 years of age on day of consent
Identified biologically male at birth
Timeline
Screening 3 weeks
Treatment Varies
Follow Up this outcome will be measured at 24-weeks post intervention.
Awards & highlights

Study Summary

This trial will help researchers learn if using an antibacterial mouthwash can help reduce the incidence of pharyngeal gonorrhea, especially in people who are HIV-positive or at high risk for HIV.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects are not specified but may include reactions related to alcohol content or allergies specific to ingredients in the mouthwashes being tested.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 45 years old.
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I was identified as male at birth.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~this outcome will be measured at 24-weeks post intervention.
This trial's timeline: 3 weeks for screening, Varies for treatment, and this outcome will be measured at 24-weeks post intervention. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adherence and acceptability of mouthwash use
Laboratory identified pharyngeal gonorrhea

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Listerine Cool Mint Antiseptic MouthwashActive Control1 Intervention
Daily use of an antibacterial mouthwash (Listerine Cool Mint Antiseptic Mouthwash) during the 12-week follow-up period.
Group II: Biotene Oral RinsePlacebo Group1 Intervention
Daily use of a placebo mouthwash with no known antibacterial qualities (Biotene Oral Rinse) during the 12-week follow-up period.

Find a Location

Who is running the clinical trial?

University of California, Los AngelesLead Sponsor
1,530 Previous Clinical Trials
10,264,608 Total Patients Enrolled
6 Trials studying Gonorrhea
3,906 Patients Enrolled for Gonorrhea
Marjan JavanbakhtPrincipal InvestigatorUniversity of California, Los Angeles

Media Library

Biotene Mouthwash (Antibacterial Agent) Clinical Trial Eligibility Overview. Trial Name: NCT04966507 — Phase 2
Gonorrhea Research Study Groups: Biotene Oral Rinse, Listerine Cool Mint Antiseptic Mouthwash
Gonorrhea Clinical Trial 2023: Biotene Mouthwash Highlights & Side Effects. Trial Name: NCT04966507 — Phase 2
Biotene Mouthwash (Antibacterial Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04966507 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are adults aged 30 and up eligible for participation in this trial?

"For this trial, only those aged 18 to 45 are eligible for participation. For younger and older individuals, there are 13 studies specifically tailored to minors and 34 trials catered towards seniors respectively."

Answered by AI

Are there any limitations on the total number of participants in this clinical research?

"Affirmative. Clinicaltrials.gov reveals that this medical trial is actively engaging patients; it was published on February 17th 2022 and its specifications were last updated on November 2nd 2021. A hundred participants are needed at one site for the duration of the study."

Answered by AI

Has the FDA sanctioned Listerine Cool Mint Antiseptic Mouthwash?

"Although there is evidence of safety, the absence of data supporting efficacy led to our team at Power assigning Listerine Cool Mint Antiseptic Mouthwash a score of 2 on its scale from 1 to 3."

Answered by AI

Is there an opportunity for me to participate in this medical experiment?

"This clinical trial seeks to enrol 100 individuals aged 18-45 with a diagnosis of gonorrhea. Key inclusion criteria include being willing and able to provide information for contact tracing, undergoing STD testing at each study visit (with reporting and treatment referral when necessary), consenting to local STI reporting requirements, having unprotected anal intercourse with another male in the last 6 months if HIV negative at screening, current enrollment in mSTUDY, 18-45 years old on date of providing informed consent, biologically male identification at birth, willingness to attend follow up visits every six months while the trial is ongoing as well as ability and commitment to returning for all"

Answered by AI

Are there still vacancies for the clinical trial that are available to be occupied by patients?

"Affirmative. Clinicaltrials.gov has the latest information which indicates that this medical study, initially posted on February 17th 2022, is actively recruiting participants. The research project requires 100 volunteers from 1 site for its completion."

Answered by AI

What afflictions is Listerine Cool Mint Antiseptic Mouthwash intended to address?

"Listerine Cool Mint Antiseptic Mouthwash is an effective remedy for alleviating pain as well as tackling other issues such as catarrh, psoriasis, and disinfection."

Answered by AI

Has any further research been conducted on the efficacy of Listerine Cool Mint Antiseptic Mouthwash?

"Presently, 29 trials are currently active for Listerine Cool Mint Antiseptic Mouthwash with 6 in the third stage of development. Primarily conducted out of Indianapolis, Indiana, these experimental studies have expanded to 1167 different locations worldwide."

Answered by AI
~10 spots leftby Aug 2024