View clinical trials related to Colitis, Ulcerative.
Filter by:The purpose of this study is to characterize the treatment patterns associated with biologics agents use or non-biological therapy in participants with moderate to severe Ulcerative Colitis (UC) and Crohn's Disease (CD).
The study will investigate the efficacy and safety of an oral dose of AJM300 960 milligram (mg)/dose administered three times daily for 8 weeks in participants with active ulcerative colitis.
There is limited data to guide the use of dietary change in the management of IBD, and it can prove challenging to implement in the setting of altered anatomy, comorbid conditions, and patient compliance. Therefore there is an important need to study diet as a therapy for IBD. Here, the investigators propose a novel study to evaluate the feasibility and efficacy of the autoimmune protocol (AIP) diet in patients with active Crohn's disease (CD) and ulcerative colitis (UC).
Ulcerative colitis (UC) is a chronic inflammatory bowel disease associated with recurrent mucosal inflammation. Clinically, the disease is characterized by bloody diarrhea, abdominal pain, and constitutional symptoms such as fever and weight loss. Treatment strategies vary based on disease activity and target various aspects of the inflammatory cascade. Options include: anti-inflammatory drugs (mesalamine), immunosuppressive or modulatory medications (corticosteroids, thiopurines, cyclosporine) and biologic agents (Anti-TNF). Disease severity can be wide ranging, and nearly 25% of UC patients are hospitalized for acute severe disease. Of these patients, 30% will undergo colectomy after the acute episode, a quarter of which will experience post-operative complications. Although there has been great progress in treatment of UC over the past decade, even with the anti-TNF agent infliximab, the one-year remission rate for patients not responding to conservative management is barely 20%. Furthermore, corticosteroids have significant long-term consequences and immune suppressive drugs such as 6-mercaptopurine, azathioprine and infliximab have been associated with serious adverse events including life-threatening infections and lymphomas. With growing evidence that the pathogenesis of UC is multi-factorial and involves a complex interaction of genetic and environmental factors, newer treatment modalities are being evaluated to target the mucosal immune response and mucosal inflammatory regulatory system. Hyperbaric oxygen offers a promising new treatment option since it targets both tissue hypoxia and inflammation. Recent small scales studies evaluating the impact of hyperbaric oxygen treatment in acute ulcerative colitis flares demonstrated improved outcomes. The mechanisms underlying the improvement are not known. In this study, we will treat ulcerative colitis flares with hyperbaric oxygen and measure changes in both markers of tissue hypoxia and inflammation. We hypothesize that hyperbaric oxygen will (a) improve outcomes, and (b) show reductions in markers of both tissue hypoxia and inflammation.
The purpose of this study is to evaluate the percentage of moderate to severe IBD participants with active disease at Day 1.
This clinical trial is the first-in-human study of BBT-401-1S. The purpose of this phase 1 study is to assess the safety and tolerability of single and multiple ascending oral doses of BBT-401-1S in healthy adult subjects.
This trial has two sequentially enrolling parts with different objectives. The primary objectives of this trial are - to prove the concept of clinical activity of BI655130 (SPESOLIMAB) in patients with moderate-to-severely active ulcerative colitis who have failed previous biologic treatments and to identify efficacious and safe dose regimens in Part 1 (Phase II) - to confirm efficacy and safety of BI655130 (SPESOLIMAB) in patients with moderate-to-severely active ulcerative colitis who have failed previous biologic treatments in Part 2 (Phase III) - To provide, along with induction study 1368-0018 and the run-in cohort of 1368-0020, the target population to be evaluated in study 1368-0020.
Alterations in the intestinal microbiota have been associated to disease pathogenesis in ulcerative colitis. Refractory disease to standard medical therapy as corticosteroids often leads to an unfavourable course in patients suffering from this disorder. This study proposal aims at investigating changes in the intestinal microbiota that can predict a therapy refractory course of ulcerative colitis (UC) and may be used to identify high risk patients in an early phase of their disease.
The purpose of this observational study is to assess the safety and effectiveness of biosimilar Infliximab in patients with inflammatory bowel disease (IBD) in Saudi Arabia where no visits or intervention(s) additional to the daily practice will be performed.
To demonstrate non-inferiority in efficacy of FE 999315 to mesalazine in patients with mild to moderate active ulcerative colitis after 8 weeks of treatment.