Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

Testing Insulin Enemas for Ulcerative Colitis: A First-Stage Clinical Trial

This study is a very early-stage trial exploring a new approach for people with ulcerative colitis. Researchers are investigating whether giving insulin as an enema could be a helpful treatment. This is the first time this specific treatment is being tested in humans. The main goal is to check if it's safe and well-tolerated by the body. This kind of early study tells us important information about safety before moving on to larger trials that look at how well a treatment works. It's a small step, but a necessary one, in understanding if this new method could eventually offer a different option for managing ulcerative colitis.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

EnteroTarget ApS

Enrolment target

Start

06 Sep 2024

Ulcerative colitis

What is this study about?

If you have ulcerative colitis, you know how challenging it can be to manage. Researchers are always looking for new and better ways to help people living with this condition. This particular study is quite exciting because it's looking into something completely new: using insulin, a hormone we usually associate with diabetes, in a different way to treat ulcerative colitis. They're giving it as an enema – a liquid put into the bottom – hoping it might help locally where the inflammation is.

This study is a very early, first-stage trial. Think of it like a brand new recipe being tested in a small kitchen before it goes into a big restaurant. The main purpose at this stage isn't to see how well it works to reduce symptoms, but rather to make sure it's safe for people to take and to understand how their bodies react to it. It’s about checking for any unexpected side effects and finding the right way to give the treatment.

By taking part in such a study, you could be helping scientists understand if this new idea has the potential to become a future treatment option. Even if it doesn't directly help your symptoms, the information gained is incredibly valuable for people with ulcerative colitis in the long run. It's a crucial step in medical discovery.

Key takeaways

This is an early-stage study testing a new insulin enema for ulcerative colitis.
The main goal is to check if the treatment is safe for people to use.
It's the first time this specific treatment is being tested in humans.
Participants must be 18 years or older, both men and women can join.
Taking part helps advance knowledge for future ulcerative colitis treatments.
You would be closely monitored by a healthcare team throughout the study.

Who may be eligible?

To be able to join this study, there are a few general things that would make you suitable. First, you need to be an adult, 18 years old or older. The study is open to both men and women.

Because this is an early study, there will likely be other specific health requirements or conditions that mean you can or cannot take part. These details are really important for the researchers to make sure the study is safe and that they get clear results. For example, they might look at how severe your ulcerative colitis is, what other medicines you are taking, or if you have other health conditions.

The best way to find out if this study is right for you is to talk to your doctor or the study team. They can go through all the detailed requirements and explain why each one is important.

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 ulcerative colitis?
Are you able to attend regular appointments at a clinic?
Are you comfortable with receiving an enema?
Are you willing to follow study instructions carefully?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would primarily be helping researchers understand the safety of this new treatment. Initially, you would have a screening visit to check if the study is a good fit for you based on the eligibility criteria. If you qualify, you would then receive the insulin enema treatment as guided by the study team. This would involve regular visits to the research clinic, likely for a set period, where doctors and nurses would monitor your health closely, take blood samples, and ask about any side effects you might be experiencing. The total duration of your involvement could vary depending on the study design, but generally, early-stage trials are shorter and focus on careful monitoring. You'd have follow-up appointments after the treatment period to ensure your well-being.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of this study is that you would be receiving an experimental treatment that might offer a new way to manage your ulcerative colitis, although the main goal of this early study is safety, not direct symptom improvement. You would also be closely monitored by a healthcare team, which means any changes in your health would be noticed quickly. Potential risks could include side effects from the insulin enema, which might be mild, moderate, or, in very rare cases, serious. As this is a new treatment in humans, not all side effects are known. 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.

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Unverified
Poland

Common questions

What is ulcerative colitis?

Ulcerative colitis is a long-lasting condition where the lining of your large intestine (colon and rectum) becomes inflamed and develops tiny ulcers.

What is an enema?

An enema is a liquid put into your bottom, usually to help with bowel problems or to deliver medication directly to the large intestine.

Why use insulin for ulcerative colitis?

Researchers are exploring if insulin, when delivered to the colon, might have properties that help reduce inflammation, though this is a new idea being tested.

Will this treatment cure my ulcerative colitis?

No, this is a very early study focused on safety, not on finding a cure. It's a step towards understanding if this could potentially be a treatment option in the future.

Will I get paid for taking part?

Study participation usually doesn't involve payment for taking part directly, but sometimes travel expenses or other costs might be covered. You should ask the study team about this.