A randomized, triple-blind, placebo-controlled study on the effect of rifaximin on psychobiological functions in healthy men.
This research study is investigating how a medicine called Targaxan (also known as rifaximin) might impact how healthy men react to stress and fear. The researchers want to see if this medicine can change how the body and mind handle stressful situations. They will measure various things like stress hormones in saliva, how people feel about stress, skin changes linked to stress, and gut health. This is an early-stage study (Phase II) to explore if there's a potential benefit for future research. Only men aged 18 and over, who are otherwise healthy, are invited to take part.
At a glance
What is this study about?
This research study, called a clinical trial, is looking into a medicine known as Targaxan (you might also hear it called rifaximin). The main goal is to understand if this medicine has any effect on how healthy men react to stressful situations and fear. Researchers are particularly interested in what they call 'psychobiological functions,' which simply means how our minds and bodies work together, especially when we're stressed.
To figure this out, scientists will be looking at several things. They'll measure stress hormones in saliva, ask participants to rate their stress levels, check for changes in skin that can happen with stress, and see how much people expect something 'dangerous' to happen in certain situations. They'll also be investigating other factors, like the balance of bacteria in the gut, how the heart rate changes, and even what's happening in the brain using special scans.
This is a 'Phase II' study, which means it's still quite early. The researchers are exploring whether Targaxan has any promise in this area before potentially moving on to larger studies. The findings from this research could help us better understand the links between our gut health, our brains, and how we cope with stress.
Key takeaways
- This study is for healthy adult men.
- It's exploring how Targaxan might affect stress and fear responses.
- You might receive the active medicine or a dummy pill (placebo).
- It's a 'blinded' study – neither you nor the doctors will know which you receive.
- Participation involves clinic visits and various health assessments.
- Findings could help us understand the gut-brain link in stress.
Who may be eligible?
This study is specifically looking for healthy, adult men. To take part, you must be male and at least 18 years old. There's no upper age limit, so men of any adult age can consider joining, as long as they are healthy.
Being 'healthy' means that you don't have any major ongoing health conditions that could affect the study results or your safety within the trial. The research team will carefully check your health to make sure you're a good fit for the study.
It's important to remember that this study is only open to men. Women cannot participate in this particular research trial.
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 male?
- Are you at least 18 years old?
- Do you generally consider yourself to be in good health?
- Are you willing to potentially take a study medicine or a placebo?
- Are you comfortable with regular clinic visits and health checks?
What does participation involve?
If you decide to take part in this study, you'll be one of the participants. This study is 'triple-blind,' which means you, your doctors, and the research team won't know whether you're receiving the active medicine (Targaxan) or a dummy pill (placebo). The placebo pill looks exactly like the real medicine, so no one can tell the difference.
During the study, you would likely have several visits to the clinic. At these visits, the research team will carry out various assessments. These could include providing saliva samples to check stress hormones, completing questionnaires about how you're feeling, having your skin examined for stress responses, and potentially undergoing brain scans. They will also collect samples to check your gut bacteria and other body markers. You would be given either the Targaxan or the placebo tablets to take as instructed. The total duration of your involvement in the study, including all visits and follow-up, would be explained in detail by the research team.
Potential risks and benefits
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Common questions
What is Targaxan (rifaximin) used for normally?
Targaxan is primarily used to treat certain gut issues, like traveller's diarrhoea or irritable bowel syndrome (IBS) with diarrhoea.
Why are they using a placebo?
A placebo helps researchers compare the effects of the actual medicine with doing nothing, making sure any changes seen are truly due to the medicine and not just other factors.
What does 'triple-blind' mean?
It means that you, the research team, and the doctors overseeing the study will not know whether you are receiving the real medicine or the dummy pill until the study is over. This helps keep the results fair and unbiased.
Will I know my own results from the tests?
Generally, individual results are not shared during the study period to maintain the 'blinding.' However, you can discuss with the research team what information might be available to you after the study concludes.
Do I have to pay to join the study?
No, you should not have to pay to participate in a clinical trial. All study-related medication and assessments should be provided free of charge.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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