Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A single blind, placebo controlled, single center, randomized controlled pilot study to assess if low dose ciprofloxacin can induce antimicrobial resistance in Escherichia coli

This study aims to understand if giving a low dose of a common antibiotic called ciprofloxacin can cause bacteria in your gut, specifically E. coli, to become resistant to antibiotics. Antibiotic resistance means that medicines might stop working against infections, which is a growing health concern. Researchers will compare people who receive a small dose of ciprofloxacin with those who receive a placebo (a dummy drug). By doing this, they hope to see how different bacteria respond and if resistance develops. The study will look at changes in the bacteria over time to help us learn more about how to use antibiotics wisely and prevent resistance.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Institute Of Tropical Medicine

Enrolment target

Start

13 Nov 2023

antimicrobial resistance in Escherichia coli

What is this study about?

This research study is trying to find out if using a small amount of a common antibiotic, ciprofloxacin, can lead to bacteria in your body, particularly E. coli, becoming resistant to antibiotics. E. coli is a type of bacteria naturally found in your gut, and while many types are harmless, some can cause infections. When bacteria become 'resistant', it means antibiotics that once killed them or stopped their growth no longer work effectively. This is a big problem because it makes infections harder to treat.

The study will involve giving some participants a low dose of ciprofloxacin and others a 'dummy' treatment (placebo) that looks just like the real drug but contains no active medicine. This helps the researchers compare the effects of the actual antibiotic against no treatment without participants knowing which they are receiving. By carefully checking samples, they want to see if the ciprofloxacin makes the E. coli in people’s guts change and become resistant.

Understanding how even small doses of antibiotics might contribute to resistance is really important. This information can help doctors and health organisations make better guidelines for using antibiotics, aiming to keep them effective for future infections and protect public health.

Key takeaways

This study investigates if low-dose antibiotics cause resistance.
It focuses on E. coli bacteria in the gut.
Participants will receive either a drug or a dummy pill.
The findings could help guide future antibiotic use.
It aims to protect the effectiveness of antibiotics for everyone.

Who may be eligible?

To be considered for this study, you need to be an adult, aged 18 years or older. There is no upper age limit, meaning people of all adult ages can take part. Both men and women are welcome to participate in this research.

The study is looking for healthy volunteers who do not have any conditions that would make taking antibiotics or participating in the study unsafe. Specific details about these conditions would be discussed with you by the research team.

It's important that you are generally well and able to follow the study's instructions and attend appointments. The research team will review your health information to make sure the study is a good fit for you.

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?
Are you comfortable with the idea of taking a study medicine or placebo?
Are you able to attend appointments at a study center?
Are you willing to provide samples, such as stool samples?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be asked to visit the study center on several occasions. You would be given either a low dose of the antibiotic ciprofloxacin or a placebo (a dummy drug) to take. You wouldn't know which one you are receiving. Over the course of the study, samples would be collected, likely including stool (poo) samples, at different times. These samples will help the researchers check for any changes in the bacteria in your gut. There will also be check-ups to make sure you are feeling well. The exact number of visits, duration of taking the study drug, and follow-up period would be explained in full detail by the study team.

Potential risks and benefits

Participating in research always carries some potential benefits and risks. A potential benefit of this study is contributing valuable information to science about antibiotic resistance, which could help improve public health in the future. As for risks, taking ciprofloxacin can have side effects, which the study team will discuss with you. These might include stomach upset or other reactions. Even though it's a low dose, there's a chance it could affect your gut bacteria, which is what the study is trying to measure. You have the right to withdraw from 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
Belgium

Common questions

What is E. coli?

E. coli is a common type of bacteria found in your intestines. Most E. coli are harmless, but some can cause illness.

What does 'antibiotic resistance' mean?

Antibiotic resistance means that a medicine (antibiotic) that used to kill bacteria or stop them from growing no longer works effectively.

What is a placebo?

A placebo is a 'dummy' treatment that looks like the real drug but contains no active medicine. It helps researchers compare results fairly.

Why is it important to study antibiotic resistance?

It's important because if antibiotics stop working, common infections could become very difficult to treat, making us sicker for longer or even posing serious risks for future health.

Will I know if I'm getting the real drug or the placebo?

No, this is a 'single blind' study, meaning you won't know if you're receiving the antibiotic or the placebo. This helps ensure the results are unbiased.