Learn More About Ulcerative Colitis Clinical Trials

What Are Ulcerative Colitis Clinical Trials?

Ulcerative colitis is an idiopathic bowel disease that causes ulcers, irritation, and inflammation in the digestive tract. Ulcerative colitis commonly affects the innermost lining of the large intestine, called the rectum and colon. The disease starts in the rectum and extends continuously through the colon. The most recognizable symptom of ulcerative colitis is bloody diarrhea. However, most patients may not report any symptoms for life.

There is no cure for ulcerative colitis, and treatments primarily focus on improving patient outcomes. Researchers classify ulcerative colitis as an autoimmune condition because the immune system mistakes friendly bacteria for a harmful infection. This causes inflammation of the rectum and colon. Medications are often used to help with the inflammation, and surgery may be used as a last resort in severe cases of the condition.

It is markedly difficult for doctors to effectively diagnose ulcerative colitis without taking a tissue sample through an endoscopic procedure. Although doctors may use radiographic findings to aid in diagnosing ulcerative colitis, they continue to rely on endoscopy for a definitive diagnosis.

However, they may use less invasive techniques to rule out other diseases. More ulcerative colitis research studies are needed to learn how the immune system, genetics, and environment play a role in disease pathophysiology.

Why Is Ulcerative Colitis Being Studied Through Clinical Trials?

Ulcerative colitis affects 2 to 7 in every 100,000 people and is responsible for 20,000 hospitalizations and 250,000 visits to physicians. More ulcerative colitis clinical trials are needed to explore the pathophysiology of the disease. The current research suggests that genetic and environmental factors may lead to ulcerative colitis.

Researchers have also linked problems with gut health to ulcerative colitis and other chronic conditions. One ²⁰²⁰ study from the Stanford University School of Medicine studied the effect of colectomy with ileal pouch anal anastomosis on gut microbes. It was found that patients with UC who developed pouchitis after surgery had low levels of Ruminococcaceae bacterium in their digestive systems.

It is also hypothesized that people with UC may improve their symptoms if they make specific dietary changes. There is a large interindividual variability in how people respond to diets. Scientists are currently interested in exploring the effects of the Mediterranean diet and if it helps patients with UC. A ²⁰²¹ review of studies found a correlation between a higher quality of life and lower disease activity in patients on a Mediterranean diet.

Very recently, the FDA approved tofacitinib (a Janus kinase inhibitor) to help in the treatment of moderate to severe ulcerative colitis. Tofacitinib has been shown to bring ulcerative colitis into remission after 52 weeks of treatment. This breakthrough opened the possibility of treating UC with other JAK inhibitors. Other areas of interest for treating UC include stem cell transplant, fecal microbiota transplant, and using interleukin 23 inhibitors.

What Are The Types of Treatments Available For Ulcerative Colitis?

There is no permanent cure for ulcerative colitis, and most treatment plans focus on managing symptoms and improving the patient’s quality of life. A major problem in treating ulcerative colitis is effective diagnosis. Doctors often have to use endoscopic procedures with tissue biopsy to diagnose ulcerative colitis. They may carry out other tests to rule out diseases with similar symptoms, such as Crohn's disease and inflammatory bowel disease.

In addition, doctors may require blood tests to look for signs of inflammation or infection. A stool sample may be collected to inspect white blood cells and proteins in the stools that could indicate ulcerative colitis. Stool samples help rule out infections that viruses, parasites, and bacteria may cause.

Treatment for ulcerative colitis may involve the use of medication or surgery. The latter is reserved for severe cases of ulcerative colitis. Depending on the symptoms, doctors may prescribe different types of medication to treat ulcerative colitis. Finding the right combination of medication may be a trial and error process. Moreover, some medicines have serious side effects that must be properly understood before use.

Common medications include 5-aminosalicylates and corticosteroids for managing inflammation. This may be followed by immune system suppressants such as Azathioprine and Cyclosporine to reduce inflammations. Depending on the symptoms, other medications may be prescribed, including pain relievers, iron supplements, and anti-diarrheal medications.

Surgery is used as a last resort measure for eliminating ulcerative colitis and may involve the complete removal of the colon and rectum. This procedure uses ileoanal anastomosis (J-pouch) surgery, removing the need to wear a bag to collect stool. This pouch is constructed from the end of the small intestine and is directly connected to the anus, allowing the patient to expel fecal matter.

What Are Some Recent Breakthrough Clinical Trials For Ulcerative Colitis?

2005: Infliximab for Induction and Maintenance Therapy for Ulcerative Colitis - Infliximab is a monoclonal antibody that has been effectively used in treating Crohn’s disease. This randomized clinical trial studied the use of the drug on ulcerative colitis. 364 patients were randomized to receive placebo or intravenous infliximab (depending on their body weight).

The study’s endpoint was a reduction in the Mayo score of at least 3 points and 30%, with a decrease in subscore for rectal bleeding of at least 1. It was found that patients with ulcerative colitis treated with infliximab had better clinical outcomes than patients who received a placebo.

2009: Infliximab in Patients with Ulcerative Colitis - Infliximab is effective at treating ulcerative colitis; up to 30% of patients have reached remission. Researchers studied the resistance mechanism to anti-tumor necrosis factor-alpha (anti-TNFalpha), given that it was previously unknown. They used colon mucosal gene expression for measuring a predictive response signature in UC patients who took infliximab treatment.

Pre-treatment colonic mucosal expression profiles were compared for responders and nonresponders. This analysis identified 179 differentially expressed probe sets in cohort A and 361 in cohort B. The top five differentially expressed genes in both cohorts were stanniocalcin-1, interleukin 13 receptor alpha 2, interleukin 11, osteoprotegerin, and prostaglandin-endoperoxide synthase 2. Further gene array studies are required to fully explore the mechanisms of resistance to infliximab therapy in UC

2017: Multidonor Intensive Fecal Microbiota in Patient with UC - This randomized controlled clinical trial investigated the use of fecal microbiota transplantation for managing active ulcerative colitis Patients were randomly allocated with AC to receive either fecal microbiota transplantation or placebo colonoscopy infusion. This was followed by enemas for 5 days for 8 weeks.

The study’s endpoint was steroid-free clinical remission with endoscopic remission or response. This was achieved in 11 of 41 patients who received fecal microbiota transplants compared to 3 who were assigned placebo. Adverse side effects were reported by 32 of 41 patients and 33 of 40 who were assigned a placebo. This study shows that fecal microbiota can induce clinical remission in patients with active ulcerative colitis. However, more studies are needed to precisely define the ideal treatment intensity and investigate the impact of donor receipt matching.

2019: Specific Bacteria with Response to Fecal Microbiota Transplantation in Patients with UC - This study builds up on early findings that fecal microbiota transplantation (FMT) could cause remission in patients with UC and improve their quality of life. 81 patients were randomized into groups receiving intensive multi-donor FMT or placebo enemas. Researchers collected 314 fecal samples from the patients every 4 weeks during the treatment.

After eight weeks of therapy, they also collected 160 large bowel biopsy samples for patients. It was found that fecal microbiota transplantation increased microbial diversity and composition. The researchers were able to associate specific metabolic pathways with the induction of remission in patients with FMT.

2021: Upadacitinib Treatment in Patients with Moderate to Seve Ulcerative Colitis - This randomized clinical trial investigated the use of upadacitinib to improve health-related quality of life outcomes in patients with Ulcerative Colitis. Patients aged 18 to 75 were randomized to receive either upadacitinib or a placebo. Their abdominal pain and bowel urgency were evaluated throughout the study.

It was found that a large number of patients (n=250) had less abdominal pain and no bowel urgency following upadacitinib treatment when compared to the placebo group. Improvements were observed as early as two weeks. Patients who received the highest dose of upadacitinib saw the most significant improvement in their quality of life compared to the placebo group.

2022: Efficacy of Maintenance Ustekinumab for UC - This ulcerative colitis clinical trial investigated the safety and efficacy of subcutaneous 90 mg ustekinumab through 3 years of therapy. Patients were randomized to receive ustekinumab every 12 weeks (q12w) and every eight weeks (q8w). Several factors were assessed, including symptomatic remission and safety. It was found that corticosteroid-free symptomatic remission rates in the ustekinumab groups were over 50%. This confirms the efficacy of ustekinumab in patients.

Who Are Some Of The Key Opinion Leaders and Institutions Conducting Ulcerative Colitis Clinical Trial Research?

Jill Roberts Institute for Research in Inflammatory Bowel Disease is a leading center for understanding the primary causes of ulcerative colitis and Crohn’s disease. The institute collaborates with Jill Roberts Center to research how gut microbes and genetic factors contribute to inflammation. Investigators at the institute also work with clinicians and surgeons to enlist UC patients for furthering various clinical trial programs.

Center for Inflammatory Bowel Disease at UCLA was founded in 2007 and focused on various aspects of therapy, diagnoses, and pathophysiology for IBD and ulcerative colitis. Their research has played an essential role in learning about the pathogenesis of these diseases at a cellular and molecular level. The research center is also helping doctors develop new therapeutic approaches for the disease.

Crohn’s & Colitis Foundation aims to improve research and learn more about ulcerative colitis and Crohn’s disease to develop novel treatment plans. The foundation has established three clinical research networks that address essential questions that positively impact patient care. The group provides researchers and doctors with resources for managing UC. Their collaborative centers have played an important role in expediting the time needed for approving studies.