View clinical trials related to Ulcerative Colitis.
Filter by:Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine). The purpose of this study is to assess how safe and effective lutikizumab is in adult subjects with UC and how lutikizumab compares to adalimumab in the treatment of UC. Adverse events and changes in disease activity will be assessed. Lutikizumab is an investigational product being developed for the treatment of UC. Participants are placed in groups called treatment arms. Each group receives a different treatment. In the Induction Period, participants will be randomized into 1 of 3 arms receiving lutikizumab Dose 1, lutikizumab Dose 2, or adalimumab. In the Maintenance Period, participants who responded to lutikizumab will be randomized into 1 of 2 arms of lutikizumab maintenance and participants who responded to adalimumab will continue to receive adalimumab. All participants who did not achieve clinical response per modified Mayo Score at the end of the Induction period will receive open label lutikizumab. Around 200 adult participants with UC will be enrolled at approximately 280 sites worldwide. In the Induction Period, participants will be randomized to receive intravenous (IV) and subcutaneous (SC) lutikizumab or SC adalimumab for 12 weeks. At the 12 week mark, participants who are on lutikizumab who have responded to treatment will be re-randomized to receive SC lutikizumab at different intervals until Week 52. Participants who are on adalimumab who are responding to treatment will continue to receive adalimumab until Week 52. Participants who do not respond to treatment will receive open-label SC lutikizumab until Week 52. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
The main aim of this study is to learn if TAK-279 reduces bowel inflammation and symptoms compared to placebo. Another aim is to compare any medical problems that participants have when they take TAK-279 or placebo and how well the participants tolerate any problems. The participants will take capsules of either TAK-279 or placebo for up to 3 months (12 weeks). Then all the participants will receive TAK-279 for the rest of the treatment part of the study (1 year or 52 weeks). During the study, participants will visit their study clinic several times.
The goal is to evaluate gastrointestinal symptoms and fatigue levels during a period of eating gluten free compared to a period of high gluten consumption in individuals with confirmed Ulcerative Colitis, and to identify clinical characteristics in the blood and microbiome of those improving from a gluten free diet. The main questions, the project aims to answer are: - What is the effect of eating gluten free on patient-reported gastrointestinal symptoms in patients with Ulcerative Colitis? - What is the effect of eating gluten free on patient-reported fatigue levels in patients with Ulcerative Colitis? - What are clinical differences between those improving and not improving on fatigue levels and gastrointestinal symptoms? During two study periods of one week each, participants will be eating gluten free supplemented with daily granola bars without and with high gluten content, respectively. During each active week, participants are asked to: - Eat gluten free and two daily granola bars delivered by the research team - Collect blood, stool and urine samples - Answer questionnaires about their symptoms, disease course, habitual lifestyle, and compliance to the protocol
The aim of this study was to evaluate the efficacy and safety of transcutaneous electrical acustimulation in patients with mild to moderate ulcerative colitis.
Ulcerative Colitis (UC) is a chronic Inflammatory Bowel Disease characterized by chronic inflammation of the colon. Composition of gut microbiota of UC patients is abnormal (dysbiosis). Ulcerative Colitis patients have an increased risk of Clostridioides difficile infection (CDI) and CDI complications (colectomy, death, recurrence). The reason for this increased risk in IBD patients is not fully understood. The decrease in the proportion of secondary bile acids, induced by microbiota dysbiosis in patients with UC could favor C. difficile infection. The main objective of the study is to describe the composition of bile acids (primary and secondary) in children followed for UC during relapse with or without CDI and to compare it to children with UC in remission and healthy controls. The composition of fecal microbiota will be also describe to correlate dysbiosis and bile acid abnormalities. And finally some fecal biomarkers will be study : short chain fatty acids, metabolic pathway of Tryptophan, and fecal Calprotectin.
A prospective observational study to assess the energy needs of Ulcerative Colitis patients undergoing total proctocolectomy with ileoanal j-pouch anastomosis.
The goal of this clinical trial is to evaluate the possible beneficial effect of silymarin in Ulcerative Colitis adult patients receiving mesalamine. This is trial that will be conducted on 44 adult patients with newly diagnosed Ulcerative Colitis. Patients will be enrolled after obtaining an informed consent from them or their guardians. Patients will be recruited from Rajhy Hospital Outpatient Clinics and Health Insurance Outpatient Clinics at Mabarra Hospital in Assiut, Egypt. The patients will be randomized based on hospital admission days into two groups: - Group Ⅰ (control group): 22 patients will receive mesalamine (4g\day induction & 2g\day maintenance) only for 6 months. - Group Ⅱ (silymarin group): 22 patients will receive mesalamine (4g\day induction & 2g\day maintenance) and silymarin (140 mg\day) for 6 months. The primary outcome will be clinical improvement defined as a 2 point or more decrease in the Mayo score from baseline. The secondary outcomes will be the change in the level of fecal calprotectin, superoxide dismutase and TNF-α.
First-in-human study to provide an assessment of the safety, tolerability, pharmacokinetics (PK), including food effects and a drug-drug interaction, and pharmacodynamics (PD) of OD-07656 after administration of ascending single and multiple oral doses to healthy male and female participants in view of treating inflammatory bowel disease (IBD) (including Crohn's disease and ulcerative colitis), Blau syndrome, and spondyloarthritis
The ULTRAZ study is designed to better understand the mode of action of S1P receptor modulators. The alteration of leukocyte trafficking due to S1P receptors such as ozanimod is mainly investigated in rodent studies. Several previous studies show a reduced total leukocyte count in peripheral blood and only two study reported the effect of leukocyte subgroups before and after treatment with ozanimod. The change in leukocyte subgroups in peripheral blood as well as colonic mucosa and lymph nodes have not been investigated to our knowledge. Therefore, the aim of this study is to explore the changes in these three compartments.
1. characterize the response to current medical therapy in adult with ulcerative colitis . 2. Detect prognostic factors of response of biological therapy in adult with ulcerative colitis