Choosing an Ulcerative Colitis Clinical Trial

Medically Reviewed by Minesh Khatri, MD on June 02, 2022
Written by Kendall K. Morgan
6 min read

If you have ulcerative colitis (UC), you’ve got many more treatment options today than you would have just a few years ago. This includes biologic medicines that are making a difference for many with moderate to more severe UC. The FDA recently approved a new medicine for UC you can take orally that works in a different way than any others before it. Advances like these are only possible because of clinical trials and the people who choose to participate in them.

Even though UC treatments have gotten better than they used to be, some people with UC still don’t get better with treatment in the way they’d like. There’s also no way to prevent or cure UC. That’s why researchers continue to develop and explore even more promising ways to treat UC. When they have a new medicine or treatment that they think might work, they have to test it in a clinical trial to see if it’s safe and effective for people with UC.

There are different reasons that people join clinical trials. But one reason you might choose a clinical trial is that other treatments you’ve tried aren’t working well for you. Clinical trials are the only way to try a new treatment before it’s approved. It’s also a way for you to feel like you’re helping advance treatments to help other people with UC.

To find out what trials are open right now, you could start with your doctor. Your doctor might know about trials that are open where you are treated or in your general area. You also can search online for trials anywhere in the world. Good places to look are the Crohn’s & Colitis Foundation’s Clinical Trial Finder.

Clinicaltrials.gov is another great place to search for trials. If you enter “ulcerative colitis” in the condition or disease field, you’ll find hundreds of trials. You can specify that it needs to be an open trial and click your age group, sex, and other criteria to help narrow your search to those that might be most promising in your case. Make sure to specify the country since your search will find trials running in places all over the world.

Clinical trials in UC are looking at many different kinds of treatments and approaches. The trials are constantly changing. Some examples include:

  • One study is testing whether a stem cell product could help people with UC who are thinking about switching to another biologic or having surgery because treatment isn’t working.
  • Another is testing whether it helps to take an oral UC medicine at a certain time of day.
  • Other studies are testing fecal microbiota transplants for UC. Fecal transplants are meant to deliver healthy gut bacteria in ways that might help.
  • Some trials are testing to see if certain diets may help with UC.
  • Still others are looking at whether medicine can lower the risk of colon cancer in UC.
  • Ongoing trials also are testing the long-term safety of biologics.

So there are lots of different trials out there in UC looking at different kinds of treatments and other questions related to UC treatment. If you’re interested in a clinical trial, it’s a good idea to look at everything that’s out there to see what your choices are.

This is a good question to ask your doctor. Your doctor can help you figure out if it makes sense for you to think about a trial now or down the road. If it does, then they can help you find out about trials that are open and enrolling people in your area. They can help you decide which trials might be a good fit for you.

Every clinical trial is different. They all have clear guidelines that say who can be in them. These guidelines are called “eligibility criteria.” To be in a certain trial, you’ll need to make sure you meet these.

These criteria might say how old you should be. They’ll likely say you need to have a certain diagnosis. For instance, your UC might need to be moderate to severe as defined a certain way. It might depend on what other treatments you’ve already taken and/or how you did on them. If you have certain other health conditions or need surgery, you might not be able to be in a trial. You’ll need to read the criteria for any trial you’re interested in carefully to see if it might be a possibility for you.

One thing to keep in mind is that clinical trials are done in phases. The phase of a trial can tell you something about how far along a new medicine or treatment for UC is.

  • Phase I trials test the newest drugs or treatments. These trials don’t enroll many people. The main goal is to decide on a dose and see if a new medicine or other treatment looks like it might be safe enough to use.
  • A phase II trial will include more people. It will still look at safety but it also will start to see if it looks like a medicine or treatment might work.
  • A phase III trial has even more people. It will make sure the earlier phase II results hold up. It also will look at side effects and how the new drug compares to others that are already in use.
  • A phase IV trial is done for drugs that are already available if researchers want to test it in other groups or look at long-term side effects.

Also keep in mind that clinical trials need control groups so that researchers can make comparisons and decide if a new treatment is working and how well. This means that even if you are in a clinical trial, you might not get the new treatment. If the trial is blinded, you won’t know if you are getting the new experimental treatment or not. In some cases the alternative may be another standard treatment. It also could be a placebo that doesn’t have an active medicine in it at all. You’ll want to make sure you understand how the trial is set up and what it would mean if you’re in the control group before you decide whether or not to join.

If you’ve talked to your doctor and found a trial that you think you might be a good match for, the next step is to contact a person who’s involved with the study. You should be able to find the contact information where you found other information about the trial. For example, clinicaltrials.gov has a link for contacts and locations in a green box on the top right. The trial organizers will likely ask you a series of questions to see if they think you are eligible for the trial. If they think you are or might be, they’re likely to have you go in to meet and have an exam or other tests.

It’s a good idea to prepare yourself by reading up on the trial. The trial protocol will explain exactly what the researchers plan to do. Make note of any questions you have so that you can get them answered before you make any decisions.

The researchers will also take you through a process called informed consent. They’ll explain what the trial is designed to do. They’ll also explain how much time is involved, what to expect, and any risks and benefits. If after hearing all of the details you still want to enroll, you’ll sign a consent form that lists all the information. You can keep copies of these forms and go back to them at any time.

You can drop out of a trial anytime you want. They may ask you to do a last visit and any other visits that are needed to make sure you aren’t having side effects.

While you’re in a trial, they’ll also watch you closely no matter which group you’re in. If there’s a change in your UC or symptoms, they’ll talk to you about it. If you’re not doing well or your symptoms get worse, they might suggest that you leave the trial.

  • Do you think a trial might be a good idea for me?
  • Do you know of a trial that you think I should consider or look into?
  • If not, what kind of trial should I look for?
  • Are there risks if I enroll in a clinical trial?
  • What are the benefits?
  • What will it mean for my treatment or care otherwise?
  • Will I still see you for my regular care?