AuthorisedTherapeutic use (Phase IV)Interventional

Clinical trial on the virucidal activity of different oral antiseptics against respiratory viruses.

This study is investigating how well certain mouthwashes work against respiratory viruses, like those that cause colds and the flu. Researchers are testing Betadine mouthwash and a hydrogen peroxide solution to see if they can reduce the amount of virus found in people's saliva. They are comparing these to a simple water solution to understand their effectiveness. The main goal is to find out if using these mouthwashes can help lower the viral load in the mouth, which could potentially slow down the spread of these common respiratory illnesses. This is a Phase IV study, meaning it's being conducted after the treatments are already approved for other uses, to learn more about their effectiveness for this specific purpose.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Fundacion Instituto De Investigacion Sanitaria De Santiago De Compostela

Enrolment target

810

Start

14 Apr 2025

Respiratory diseases

What is this study about?

Imagine you have a cold or the flu. This study is like a detective trying to figure out if certain common mouthwashes can send those cold and flu viruses packing! Scientists want to see if using specific mouthwashes can help get rid of some of the virus particles in your mouth, where they often live and spread from.

The researchers are testing a mouthwash called Betadine and a hydrogen peroxide solution, comparing them to just plain water. They believe that if these mouthwashes can reduce the amount of virus in your saliva, it might mean there's less virus to spread to others when you cough or sneeze. This could be a simple way to help manage common respiratory illnesses.

This kind of study is called a 'Phase IV' study. This means the products being tested (like Betadine mouthwash) are already approved and used for other things. Now, doctors want to learn more about how effective they are specifically against respiratory viruses when used as a mouthwash. The results could help us understand if using these mouthwashes could be a helpful step in preventing the spread of everyday illnesses like colds and the flu.

Key takeaways

Tests common mouthwashes against cold and flu viruses.
Aims to see if mouthwash can reduce virus in saliva.
Could help understand how to slow virus spread.
For adults (18+) with respiratory illnesses.
Involves using mouthwash and giving saliva samples.

Who may be eligible?

To join this study, you need to be an adult, at least 18 years old. Both men and women are welcome to take part.

This study is for people who have respiratory illnesses, such as a cold or the flu. The researchers are looking for people who can provide samples of their saliva to see how the mouthwashes affect the viruses present.

Further details about your health and any medications you are taking would be discussed with the study team to make sure it's safe and appropriate for you to participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have a respiratory illness (like a cold or flu)?
Are you open to using a mouthwash as part of the study?
Are you willing to provide saliva samples as requested?
Do you understand that both men and women can participate?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be asked to use one of the assigned mouthwashes – either Betadine, a hydrogen peroxide solution, or plain water. The researchers would collect samples of your saliva at different times after you use the mouthwash. These samples will help them measure how much virus is in your mouth. You won't need to visit a special clinic repeatedly; the process is mainly about applying the mouthwash and providing saliva samples as instructed.

Potential risks and benefits

Participating in this study might offer a small benefit by potentially reducing the viral load in your mouth, though this is what the study aims to confirm. It could also help scientists learn more about new ways to manage common respiratory viruses for everyone. Potential risks might include mild irritation from the mouthwash, which would be explained in detail. You are always free to leave the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
Spain

Common questions

What kind of viruses are being looked at?

The study focuses on common respiratory viruses, which are usually responsible for conditions like colds and the flu.

What will I have to do if I join?

You will use a specific mouthwash and provide saliva samples at certain times so researchers can check for viruses.

Are the mouthwashes safe?

The mouthwash products being tested are already approved and widely used for other purposes, but the study will still monitor your safety closely for this use.

Will I know which mouthwash I'm using?

The study design will explain whether you will know which mouthwash you are using, or if it will be given to you without that information (this is called 'blinding').

How long will the study take for me?

The study involves collecting samples at 'different times of application', so the total time commitment would be explained by the study team.