Colitis ulcerative
RecruitingStudy of LY4268989 adipic acid in adults with moderately to severely active ulcerative colitis
- Disease:Colitis ulcerative
- Substances:–
Croatia- Participants:18–64 years · 65+ years
- Sponsor:Eli Lilly & Co.
Rare diseases
Investigational molecules
Locations
Recruiting trials first
119 clinical trials in this condition
Croatia
Austria
Bulgaria
AustriaIn short
Ulcerative colitis is a lifelong inflammatory condition affecting the large intestine, but with proper treatment strategies, many people can achieve long periods of remission and maintain a good quality of life. The goal of therapy is to calm inflammation, control symptoms like bloody diarrhea and abdominal pain, and prevent serious complications without relying on steroids long-term.
When someone receives a diagnosis of ulcerative colitis, which is a chronic disease causing inflammation and ulcers in the inner lining of the large intestine, treatment becomes essential to managing daily life. The approach to treatment depends heavily on several factors, including how severe your symptoms are, which parts of your colon are affected, and how your disease behaves over time. Some people might only have inflammation in the rectum, called ulcerative proctitis, while others may have inflammation throughout the entire colon, known as pancolitis.
The main aim of treatment is not just to reduce symptoms during active flare-ups, but also to keep you in remission, which means periods when you have no symptoms at all. Achieving and maintaining remission without the need for corticosteroids is considered the gold standard. This approach helps you avoid the side effects that come with long-term steroid use while allowing you to return to normal activities and improve your overall wellbeing.
There are standard treatments that have been used successfully for many years, approved by medical societies and supported by clinical guidelines. At the same time, researchers are constantly testing new therapies in clinical trials, exploring innovative ways to control inflammation and prevent disease progression. Your treatment journey will likely involve working closely with a team of healthcare professionals, including gastroenterologists and specialist nurses, who will help tailor a plan that fits your specific situation.
Treatment selection depends on where the inflammation is located and how severe it is. For people with inflammation limited to the rectum, which is often the case when ulcerative colitis first appears, treatment usually starts with medicines that can be applied directly to the affected area.
Aminosalicylates, also known as 5-ASA compounds, are often the first line of treatment for mild to moderate ulcerative colitis. These medicines work by reducing inflammation in the lining of the colon, which allows damaged tissue to heal. They can be taken in different forms depending on which part of your colon is affected. If you have inflammation only in the rectum, your doctor may prescribe 5-ASA as a suppository that you insert into your bottom, or as an enema, where liquid medicine is pumped into your large intestine.
For more extensive disease affecting larger portions of the colon, oral tablets or capsules containing 5-ASA are used. Sometimes, combining both oral and rectal forms provides the best results because the rectal medicine reaches the inflamed area directly, helping you feel better faster. These medicines are generally well tolerated, though some people may experience side effects such as headaches, feeling sick, tummy pain, skin rashes, or diarrhea.
One of the significant advantages of 5-ASA compounds is that they can be used both to treat active flare-ups and as long-term maintenance therapy. Many people take them for the rest of their lives to maintain remission and prevent symptoms from returning.
Corticosteroids, such as prednisolone, are powerful anti-inflammatory medicines used when 5-ASA alone is not effective or when symptoms are more severe. Like 5-ASA, steroids can be given orally, as a suppository, or through an enema. They work by suppressing the immune system's overactive response that causes inflammation in the colon.
While corticosteroids are very effective at inducing remission during flare-ups, they are not suitable for long-term maintenance treatment. This is because prolonged steroid use can cause serious side effects, including weakening of the bones, a condition called osteoporosis, and cloudy patches in the lens of the eye known as cataracts. Short-term side effects of steroid use can include acne, weight gain, increased appetite, mood changes such as becoming more irritable, and difficulty sleeping.
Because of these concerns, doctors aim to get patients off steroids as quickly as possible once remission is achieved. This has led to the development and increased use of other types of medicines that can maintain remission without the risks associated with steroids.
Immunosuppressants are medicines that reduce the activity of the immune system, which is overactive in people with ulcerative colitis. Common immunosuppressants include azathioprine, 6-mercaptopurine, and tacrolimus. These medicines are usually given as tablets and are used to treat mild or moderate flare-ups or to maintain remission when other medicines have not been successful.
One important thing to understand about immunosuppressants is that they can take several weeks or even months to start working effectively. This means they are not the best choice for treating severe, sudden flare-ups, but they are valuable for long-term disease control.
Because these medicines suppress the immune system, they can make you more vulnerable to infections. It is important to report any signs of infection, such as high temperature or sickness, to your doctor promptly. Additionally, immunosuppressants can lower the production of red blood cells, leading to anemia. For this reason, you will need regular blood tests to monitor your blood cell levels and check for any other problems.
When ulcerative colitis causes severe symptoms, hospital treatment becomes necessary to minimize the risk of dehydration and potentially fatal complications such as the colon rupturing. In the hospital, medicines and sometimes fluids are given directly into a vein, which is called intravenous administration.
For severe cases, doctors may use intravenous corticosteroids or immunosuppressant medicines called ciclosporin or infliximab. Ciclosporin is given slowly through a drip in your arm, typically as a continuous infusion for about seven days. Side effects can include uncontrollable shaking or trembling, excessive hair growth, extreme tiredness, swollen gums, nausea, vomiting, and diarrhea. Ciclosporin can also cause high blood pressure and reduced kidney and liver function, so patients are monitored closely during treatment.
Biologic medicines represent a more advanced class of treatments that target specific parts of the immune system involved in inflammation. These medicines work by blocking proteins that the immune system uses to stimulate inflammation in the intestine. They are used to treat moderate to severe ulcerative colitis when other treatment options are not suitable or not working.
Biologic medicines are typically given in a hospital setting, either as an infusion through a drip in your arm every four to twelve weeks, or as an injection that you give yourself every one to two weeks. Examples include infliximab, which is a type of medicine that blocks tumor necrosis factor-alpha (TNF-α), a protein that promotes inflammation.
Beyond standard treatments, researchers around the world are working to develop new and improved therapies for ulcerative colitis. Clinical trials test these promising treatments to determine if they are safe and effective before they become widely available. These trials are usually conducted in phases, each with a specific purpose.
Phase I trials focus primarily on safety. Researchers want to know if a new medicine causes harmful side effects and what dose is safe to use. These trials usually involve a small number of participants. Phase II trials examine whether the medicine actually works to improve symptoms or other measures of disease activity. They involve more people than Phase I trials and help determine the optimal dose. Phase III trials compare the new medicine against current standard treatments or a placebo (an inactive substance) in large groups of patients. These trials provide the strongest evidence about whether a new treatment should be approved for use.
Several types of innovative medicines are being studied in clinical trials for ulcerative colitis. These include additional anti-integrin agents, which are medicines that prevent certain white blood cells from entering the intestinal tissue and causing inflammation. Anti-integrin therapies work by blocking proteins on the surface of these cells, preventing them from sticking to blood vessel walls and migrating into inflamed tissue.
Another class of medicines being investigated are anti-IL12/23 agents. These target specific molecules called interleukins that play important roles in the inflammatory process. By blocking these molecules, the medicines aim to reduce the immune system's attack on the colon lining.
JAK inhibitors represent a newer approach to treating ulcerative colitis. These are small molecule drugs that interfere with signaling pathways inside cells that promote inflammation. Unlike biologic medicines which are given by injection or infusion, JAK inhibitors are taken as oral tablets, which some patients find more convenient.
Sphingosine-1-phosphate receptor modulators are another novel class of medicines under study. These drugs work by preventing certain immune cells from leaving the lymph nodes and traveling to sites of inflammation, including the colon. By keeping these cells away from the intestine, inflammation is reduced.
Clinical trials for ulcerative colitis are conducted in many locations, including in the United States, Europe, and other parts of the world. Not everyone is eligible to participate in every trial. Researchers set specific criteria based on factors such as disease severity, previous treatments, other health conditions, and age. If you are interested in participating in a clinical trial, talk to your gastroenterologist. They can help you understand whether you might be eligible for any ongoing studies and what participation would involve.
Some clinical trials have reported promising preliminary results, such as improvements in clinical symptoms, reduction in inflammation seen during colonoscopy, and favorable safety profiles. However, it is important to remember that treatments in trials are still being studied and have not yet been proven to be definitively effective or safe for widespread use.
Ulcerative colitis is a lifelong condition, which means that treatment is typically ongoing. Even when symptoms disappear during remission, continuing medication is usually necessary to keep the disease under control and prevent flare-ups from returning. The duration of treatment during an active flare-up varies depending on severity. Mild flares might respond to treatment within a few weeks, while more severe episodes may take several months to fully resolve.
For maintenance therapy, many people take 5-ASA compounds indefinitely. The goal is to maximize the length of time you remain symptom-free. Research has shown that continuing medical therapy after achieving remission significantly reduces the chance of symptoms returning.
In some situations, surgery becomes necessary for treating ulcerative colitis. This might happen when medicines are not effective at controlling symptoms, when quality of life is significantly affected despite treatment, or when serious complications develop.
Surgery for ulcerative colitis typically involves removing some or all of the colon. During the procedure, the surgeon may create an opening in your abdomen called a stoma, through which waste from your small intestine exits the body into a bag. This type of surgery is called an ileostomy. In some cases, the stoma is only temporary and can be closed once the intestine has healed.
An alternative surgical option involves creating an internal pouch from part of the small intestine that is connected to the anus. This is called an ileoanal pouch. It allows you to pass stool normally without needing an external bag.
Emergency indications for surgery include a perforated colon (when a hole develops in the intestinal wall), toxic megacolon (severe inflammation causing the colon to stop working), and continuous severe colorectal bleeding that cannot be stopped. In these situations, close collaboration between gastroenterologists and surgeons is essential to ensure surgery is not delayed when it is urgently needed.
This guide is here to help you understand the condition. It does not replace a conversation with your doctor, who knows your situation best.
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