Ulcerative colitis is a form of inflammatory bowel disease. There is currently no cure. Various clinical trials are investigating treatments that may help ease peoples’ symptoms.

Researchers are developing novel treatments for ulcerative colitis (UC) through ongoing clinical trials. These studies look at how well the treatments work, who they are effective for, and how safe they are.

The Food and Drug Administration (FDA) only approves new treatments that have passed several stages of clinical trials.

In the early phases, researchers test treatments on small to medium groups of volunteers. Then, in later phases, they administer the treatment to larger groups of people.

Various clinical trials for UC are currently underway or in the process of recruiting volunteers. These studies may help find safe and effective new treatments that help people living with UC.

Read on to learn about what clinical trials are researching, how they work, and what participants should expect.

A researcher in a lab working on ulcerative colitis clinical trials.Share on Pinterest
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As of October 2021, over 300 clinical trials in the United States are recruiting, active, or recently completed.

People wanting to participate in clinical trials may want to use the Crohn’s Colitis Foundation’s clinical trial finder. They can also use the U.S. government’s clinical trial database.

Many UC clinical trials are currently underway. Several studies of note are:

Drug study

In March 2021, the Bristol Myers Squibb pharmaceutical company started a trial to test a medication called Deucravacitinib, or BMS-986165.

This medication may treat moderate to severe UC by moderating the immune response and controlling inflammation. The study is aiming to finish by April 2023.

The study is looking particularly for people who have tried at least one standard UC medication without success. Individuals aged 18–65 years who received a UC diagnosis at least 3 months ago can inquire about joining the trial.

Microbiome metabolic therapy study

In this study, researchers use a treatment called KB295 to treat individuals living with mild to moderate UC.

KB295 is a microbiome metabolic therapy, which is a type of therapy that affects the microbiota in the intestines. It increases their metabolite production, giving specific bacteria an advantage or disadvantage.

The overall aim of the trial is to restore a healthy digestive biome. It is currently underway and aims to end in December 2021.

Dietary intervention study

In this clinical trial, researchers are looking at how a diet that mimics fasting affects people with mild to moderate UC.

Participants will spend 5 days eating a reduced-calorie diet, and researchers will investigate if inflammatory markers have decreased and the individual’s quality of life has improved. The goal is to allow people to receive the benefits of fasting while continuing to eat.

It is currently recruiting participants and should end in May 2022.

Because UC is an inflammatory disease, many clinical trials aim to reduce inflammation and swelling. Some research explores treatments that relieve inflammation by improving immune system regulation, controlling the inflammatory process.

Other trials have looked at using cannabis to decrease inflammation associated with UC.

In the absence of a cure, researchers hope to decrease the pain and life-disrupting symptoms associated with UC.

Clinical trials are an essential part of the drug development process, and they help develop and approve treatments for many different conditions. Scientists use these studies to learn how safe and effective a particular drug, therapy, or treatment method may be.

Before using human participants, researchers usually test treatments on laboratory animals. Once they determine that a treatment is safe, they begin testing it on humans in three phases of clinical trials.

In the first phase, researchers aim to determine treatment responses in a small group of 20–100 healthy volunteers. The second phase involves testing the product on several hundred participants who have the target condition.

Phase three trials are large, involving up to 3,000 volunteers.

Researchers aim to determine whether the drug is effective and safe. If the FDA acknowledges the positive findings, they may approve the experimental medication.

All clinical trials are different, so the exact procedure varies according to the length of the trial, what researchers are studying, the location, and more.

Here are some typical steps:

  1. Pre-screening: After an individual expresses interest in volunteering for a clinical trial, a member of the study staff will call and discuss the details and gather information.
  2. Screening appointment: This visit is an opportunity for the research team and participant to gather information, ask questions, and understand the clinical trial process.
  3. Informed consent: Once an individual has had the opportunity to ask any questions and agrees to participate in the trial of their own free will, they indicate this by signing the informed consent document.
  4. Screening tests: The study staff then complete the remaining screening procedures to ensure the individual qualifies for the trial. This may include blood and urine samples, vital signs, and medical history.
  5. Baseline visit: If the researchers accept the individual into the trial, they schedule an initial visit to conduct mental and physical tests and make any assessments.
  6. Assignment: The researchers randomly assign the individual to a treatment or control group. They also dispense the study drug and directions on dosage, appropriate documentation, and any other instructions. The study coordinator will schedule further visits or tests.
  7. Trial period: The individual follows the trial procedure and reports any issues to the researchers.
  8. Study visits: The individual may visit the research facility regularly for evaluations and discussions with the study staff. At these visits, the individual can discuss any questions or issues with the study staff.

Learn more about how clinical trials work.

Without clinical trials, people would not benefit from new and effective treatments. But despite strict rules on safety, there are potential risks associated with all forms of treatment.

Individuals considering joining a clinical trial should understand the risk, including:

  • Side effects: The trial treatment could cause side effects from mild discomfort to severe reactions.
  • No improvement: The new medication may not ease a person’s symptoms.
  • Control group: Individuals may not receive the new treatment. Instead, they may be part of the control group, meaning they receive the standard treatment or a placebo.
  • Inconvenience: Individuals may need to travel to the study sites and may find these medical appointments time-consuming. Additionally, some trials require that the participants stay in the study facility.

Clinical trials for UC aim to test the safety and efficacy of new treatments.

People who volunteer for these trials may receive treatments before they are available to everyone. But there are some risks involved in participating, including side effects, experiencing no improvement, and inconvenience.

Individuals in the U.S. interested in participating in a clinical trial can find potential studies in their area by visiting clinicaltrials.gov.