RecruitingACTRN12621000929808

Oropharyngeal gonorrhoea detection using mouthwash overtime (OMEGA3)

Investigating the impact of zero alcohol mouthwash on the detection rates of oropharyngeal gonorrhoea in gonorrhoea-positive adults


Sponsor

Alfred Health

Enrollment

120 participants

Start Date

Jul 15, 2021

Study Type

Interventional

Conditions

Summary

The aim of this study is to examine whether Neisseria gonorrhoeae bacteria from the oropharynx will grow after using a mouthwash over a two-hour time period.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is examining how long Neisseria gonorrhoeae — the bacteria that causes gonorrhoea — can survive in the throat after a person uses mouthwash. Gonorrhoea of the throat (oropharyngeal gonorrhoea) is increasingly common, especially among men who have sex with men, and mouthwash has been investigated as a potential way to reduce or eliminate throat gonorrhoea. Understanding how quickly the bacteria return after mouthwash use is important for knowing how effective or temporary any benefit might be. Participants who test positive for oropharyngeal gonorrhoea and come to the Melbourne Sexual Health Centre (MSHC) for treatment will be asked to use a mouthwash and then have throat swabs taken at regular intervals over two hours to see if the bacteria can still be detected and cultured. To be eligible, you must be 18 or older, have a positive gonorrhoea test result from the oropharynx (throat), and return to MSHC for treatment within 10 days of your screening test. You must not have taken antibiotics in the past 14 days, have an allergy to mouthwash, or be currently participating in another clinical trial. This study is run by Alfred Health.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

The intervention is Listerine® Zero mouthwash. At the commencement of the study (i.e. before receiving the mouthwash intervention, t=0), the research nurse will take two throat swabs (covering the t

The intervention is Listerine® Zero mouthwash. At the commencement of the study (i.e. before receiving the mouthwash intervention, t=0), the research nurse will take two throat swabs (covering the tonsillar fossae and posterior pharyngeal wall) at baseline before they receive the mouthwash intervention. Participants will be asked to provide a saliva sample with the instruction provided by the research nurse. After collecting the throat swabs and saliva samples at baseline (t=0), participants will be instructed to use the allocated mouthwash by rinsing and gargling 10mls of the mouthwash into the back of their throat for 30 seconds (rinse for 15 seconds then gargle for 15 seconds) and then to discard the mouthwash. They will then be instructed to use the spray bottle provided to spray the mouthwash 15 times to the back of their throat and spitting the excess. The same composition of mouthwash will be used for rinsing/gargling as well as spraying with no alteration. Participants will be asked to use the mouthwash once at t=0, no mouthwash will be used after this time point. Participants will be supervised by a research nurse when using the mouthwash. The mouthwash intervention will be administered by the research nurse. After the mouthwash regime has been completed, the research nurse will set a timer for five minutes (t=5). At five minutes the research nurse will then take two throat swabs and a saliva sample. This process will be followed the same at time points of 30 minutes (t=30), 60 minutes (t=60), and 120 minutes (t=120). Composition of Listerine® Zero mouthwash: Water, Sorbitol, Propylene Glycol, Sodium Lauryl Sulfate, Poloxamer 407, Eucalyptol, Benzoic Acid, Sodium Benzoate, Methyl Salicylate, Thymol, Sodium Saccharin, Menthol, Sodium Fluoride, Flavour, Sucralose, CI 42053.


Locations(1)

Melbourne Sexual Health Centre (MSHC) - Carlton

VIC, Australia

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ACTRN12621000929808


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