Gonorrhoea is one of the most common sexually transmissible infections (STIs) globally. Gonorrhoea can infect the throat, genital and anus. Gonorrhoea is usually symptomatic at the genital site; but it is usually asymptomatic in the throat and anus.
Gonorrhoea bacteria can be found in saliva. Previous studies have suggested that the oropharynx may be an important site for gonorrhoea transmission. Current studies and trials are investigating whether the use of mouthwash could be an intervention for gonorrhoea.
The OMEGA3 study will examine whether the bacteria Neisseria gonorrhoeae from the throat will grow within two hours of using a mouthwash.
This study has been registered with the Australian New Zealand Clinical Trials Registry (ANZCTR) under ACTRN 12621000929808.
About the study
OMEGA3 study is a randomised controlled research study involving people who are positive for throat gonorrhoea. The study will compare using a mouthwash to not using a mouthwash to see the effect on the gonorrhoea bacterial growth over a two hour time period.;
What is randomised controlled research?
Randomised controlled research means that we put people into groups and give each group different treatment.
We do this so we can compare the results of the different treatments to see if one is better than the other. To try to make sure the groups are the same, each participant is put into a group by chance (random).
What's involved
If you agree to participate in the study, a research nurse will randomly allocate you to one of the two groups in the study.
- No intervention group: you will have two throat swabs and a saliva sample taken at five different time intervals over a two hour time period only.
- Mouthwash group: you will be asked to rinse, gargle and spray the allocated mouthwash at the start and have throat swabs and a saliva sample taken over a two hour period.
Participating in the study will take about 3.5 hours in total. If you agree to take part, you will need to stay in the clinic for this time. We will ask you not to eat, drink or smoke during the study period. Straight after the study requirements have been completed, we will give you treatment for your throat infection.
Who we want to talk to
Our research team will contact you during your visit to Melbourne Sexual Health Centre if you:
- are over 18 years old
- are diagnosed with gonorrhoea in the throat
If you take part in the study, we need you to stay in the clinic for an extended period of time. To compensate you for your time, we will give you a $100 gift card when you have completed the study requirements.
Ethics
All research in Australia involving humans is reviewed by an independent group of people called a Human Research Ethics Committee (HREC). The ethical aspects of this research project have been approved by the Alfred Hospital HREC.
This project will be carried out according to the National Statement on Ethical Conduct in Human Research (2007). This statement has been developed to protect the interests of people who agree to participate in human research studies. Approval has been given by the Alfred Hospital HREC which reviews ethics applications for research carried out at the Melbourne Sexual Health Centre.