View clinical trials related to Colitis, Ulcerative.
Filter by:The primary objective of this study is to evaluate sustained clinical remission (for the definition see below) in patients with inflammatory bowel disease receiving long-term (> 2 years) scheduled treatment with infliximab. Secondary objectives include: - to identify predictors of sustained clinical remission during long-term infliximab scheduled treatment - to identify predictors of loose of response during infliximab scheduled maintenance treatment - to identify predictors for maintaining clinical remission in patients who discontinue infliximab because of long-lasting steroid-free clinical remission - to evaluate percentage of surgery during and after treatment (total follow-up) - to evaluate safety of long-term infliximab scheduled treatment List the clinical hypotheses Infliximab is indicated and recommended in moderate to severe inflammatory bowel disease patients who not tolerate or are not responsive to conventional therapies. Most of randomized clinical trials about the use of infliximab in inflammatory bowel diseases are limited to 52 weeks and very few data come from some observational studies about results of prolonged (over one year) treatment with infliximab. No validated predictors of sustained clinical remission or loss of response are available so far. Moreover, few data are available about the hypothetical reduction of IBD related surgery in the "biological era". In this proposal we suggest the following hypotheses: - infliximab scheduled treatment may be efficacious in maintain long-term clinical remission; - among clinical, laboratory and endoscopic data some predictors of sustained clinical remission during infliximab long-term scheduled treatment may be found; - among clinical, laboratory and endoscopic data some predictors of loss of response during infliximab long-term scheduled treatment may be found; - among clinical, laboratory and endoscopic data some predictors of sustained clinical remission after infliximab discontinuation because of long-lasting (> 6 months) steroid-free clinical remission may be found; - maintenance of remission with infliximab may reduce rates of surgery over time; - long-term scheduled treatment with infliximab may be safe and well tolerated. Results from this study may really help clinicians to make practical decisions in these particular clinical settings.
Understanding of how best to treat inflammatory bowel disease (IBD) has evolved over the last ten years. Evidence now suggests that the most effective therapy early in the course of Crohn's disease (CD) and ulcerative colitis (UC) involves the use of immune suppressing medications such as the anti-Tumor Necrosis Factor (anti-TNF) agents infliximab, adalimumab, and certolizumab. However, many CD and UC patients still ultimately require surgery despite the use of these medications. Side effects of the anti-TNF agents include increased risk of infections due to their effect on the immune system. Little is known about how use of these medications near the time of surgery may affect patients' risks of infection or other post-operative complications. The only available studies on this topic have given conflicting results. These studies have been limited by the fact that they have been small in size and retrospective. Retrospective studies primarily involve chart review as the method of identifying potential risk factors for infections and other complications after they have already occurred. This method limits both the type and quality of information/data that can be collected. The conflicting results have led to variance in practice patterns with regards to management of anti-TNF agents, the timing of surgery, and even the types of surgery. By enrolling patients at the time of their surgery, collecting extensive information may be possible than previously studied on potential risk factors for both infectious and non-infectious complications following surgery. Risk factors to be studied will include individual patient characteristics, disease characteristics, surgical methods, novel characteristics of CT scans and MRIs and extensive medication exposures. The primary objective is to determine if exposure to anti-TNF agents prior to surgery increases the risk of infection post-operatively. And evaluate exposure to anti-TNF agents by both patient history of use and measurement of anti-TNF drug levels at the time of surgery. Monitoring of drug levels at the time of surgery has never been utilized in this way to evaluate the risk of anti-TNF agents in IBD. However, this has been done to assess the risk of other medications in different diseases. If anti-TNF agents are found to pose a risk for infectious or non-infectious outcomes in IBD patients undergoing surgery, change maybe needed in the way these medications are used around the time of surgery. Additionally, by collecting comprehensive information on other potential risk factors besides medication use patients at greatest risk for bad outcomes can be identified and take protective measures when possible. The aims of this study address the CCFA challenge to better define the risks of medical and surgical therapies to improve the quality of care of IBD patients undergoing surgery.
Ulcerative colitis (UC) is a chronic inflammatory condition of unknown aetiology, characterized by a diffuse confluent mucosal inflammation of the colon starting from the rectum with a relapsing and remitting course. Conventional endoscopy was thought to be a reliable parameter of disease activity, but microscopic inflammation can persist despite normal mucosal findings. Histologically detectable inflammation is associated with a greater risk of subsequent relapse. A flare in UC activity is difficult to predict, but a simple, easily measured biological marker of relapse would be important in guiding the most appropriate therapy. Recent technological advances in fiber optics, light sources, detectors, and molecular biology have stimulated development of numerous optical methods that promise to significantly improve our ability to evaluate human epithelium in vivo. These methods, collectively termed "optical biopsy," are nondestructive in situ assays of mucosal histopathology using light that can provide instantaneous tissue assessment. Narrow band imaging (NBI) is a novel technique that enhances the diagnostic capability of endoscopes in characterising tissues by using filters in a redgreenblue (RGB) sequential illumination system. This results in improved mucosal contrast and detail. UC always involves the distal colon and activity is usually greatest in rectosigmoid area. This makes evaluation of the rectum and sigmoid an attractive marker in patients with UC. Unlike serum and faecal markers, endoscopic assessment of the mucosa is unlikely to be affected by systemic disease and would be acceptable test for patients and physicians. We plan to evaluate THE rectosigmoid mucosa in patients with UC by flexible endoscope using both white light and NBI endoscopy. These patients will be followed by for one year or until they relapse, whichever comes first. The aim of our study is to develop endoscopic biomarkers to predict relapse in acute and quiescent UC.
The purpose of this study is to test whether Fecal Microbiota Transplant (FMT) is a safe and effective treatment for people who have Ulcerative Colitis and have had an ileal pouch anastomosis. Ulcerative colitis (UC) is a type of inflammatory bowel disease (IBD) that may be caused by a person's immune system responding in an unusual way to bacteria normally found in the gut. Studies have shown that the gut bacteria in people with ulcerative colitis (UC) are different from the gut bacteria in people without ulcerative colitis (UC). Often, people with ulcerative colitis (UC) have fewer types of bacteria in their gut which can change the way that person's immune system works. This study is for people who have had a proctocolectomy with an ileal pouch anastomosis (IPAA) to treat ulcerative colitis (UC). More than 50% of people who have had an IPAA will develop a condition called pouchitis. Pouchitis is short or long-term inflammation of the ileal pouch that was created in order to store waste from your intestines. Patients with pouchitis are being asked to take part in this study. Currently, antibiotics, probiotics and prebiotics are used to treat pouchitis. However, it has been shown that probiotics are not very helpful once the patient stops taking them. In addition, antibiotics may cause unfavorable side effects. Fecal microbiota transplantation (FMT) is being studied as another form of treatment for patients with active pouchitis. Fecal microbiota transplantation (FMT) or "stool transplant" involves receiving a single fecal enema from someone who has volunteered to donate their stool. There are two purposes of this research study: 1. To see whether or not fecal microbiota transplantation (FMT) is a useful treatment for patients with ulcerative colitis (UC) associated pouchitis 2. To study the changes within the bacteria in the gut in patients with pouchitis (before and after study treatment) using stool, blood and urine samples
The aim of this randomized trial is to investigate the effects of a 12-week yoga intervention compared to self-care on quality of life, stress, psychological health, and physiological parameters in 77 patients with ulcerative colitis.
The purpose of this study is to evaluate efficacy, safety and pharmacokinetics of the vedolizumab (MLN0002) induction and maintenance therapy in Japanese participants with moderate or severe ulcerative colitis (UC).
the etiology of Inflammatory Bowel Diseases (IBD) is closely associated with the gut microbiome. The results of previous studies on the effectiveness of antibiotics and fecal macrobiota transplantation (FMT) are contradicting. Aims: to evaluate the effectiveness of wide-spectrum antibiotic regimens in acute severe colitis in an addition to standard corticosteroid therapy (UC and isolated "UC-like" Crohn's colitis). The secondary aim is to assess the outcome of FMT in those not responding to five days of therapy (in either arm). As an exploratory aim, any IBD patient with a resistant disease to at least two immunosuppressive medications, may be treated with either interventions.
Study Hypothesis UC Disease affects the colon. PillCam IBD may be used for visualization of the colon mucosa in UC Disease patients. This study is designed to evaluate the yield and clinical impact of IBD capsule in detecting lesions associated with UC Disease and to determine the agreement between PillCam Platform with the IBD capsule and optical colonoscopy in the evaluation of UC disease extent. Primary Scientific Objective To evaluate the agreement between PillCam IBD system and optical colonoscopy in the evaluation of UC disease extent (Non-active disease, Proctitis, Left-sided colitis, Pancolitis) Proposed Design Established UC disease patients whose clinical condition suggests ongoing disease activity, aged 18 years and up, who have no evidence of symptomatic stricture or other obstruction that would prevent capsule passage will be enrolled in this study. Patients will undergo bowel prep, followed by a PillCam IBD capsule examination and colonoscopy examination. The Rapid videos will be evaluated by two readers, each from a different site, the colonoscopy videos will be evaluated by two other physicians, at the sites INCLUSION CRITERIA All subjects must fulfill all of the following inclusion criteria: - Patients ages 18 years and up - Patient has known UC according to physician discretion - Patient has at least one positive inflammatory marker from the following: - ESR - CRP - CBC - Patient is indicated and eligible for a standard of care colonoscopy examination - Patient agrees to sign consent form EXCLUSION CRITERIA The presence of any of the following will exclude a patient from study enrollment: - Crohn's Disease - Antibiotic Associated Colitis - Stool positive for O&P (C&S within 3 months of enrollment) - Other known infectious cause of increased symptoms - Known intestinal obstruction or current obstructive symptoms, such as severe abdominal pain with accompanying nausea or vomiting. - Definite long stricture seen on radiological exam. - Non-steroidal anti-inflammatory drugs including Aspirin, (twice weekly or more) during the 4 weeks preceding enrollment - Suspected GI stricture, followed by patency capsule study or other imaging study that could not prove patency of the GI tract. - Patient has had prior abdominal surgery of the gastrointestinal tract in the last 6 months, other than uncomplicated procedures that would be unlikely to lead to bowel obstruction based on the clinical judgment of the investigator. - Patient is expected to undergo MRI examination within 7 days after ingestion of the capsule. - Patient with known gastrointestinal motility disorders. - Subjects with known or suspected delayed gastric emptying - Patient suffers from any condition, such as swallowing problems, which precludes compliance with study and/or device instructions. - Patient has Type 1 or Type II Diabetes. - Patient has any allergy or other known contraindication to the medications used in the study. - Patient has any condition, which precludes compliance with study and/or device instructions. - Women who are either pregnant or nursing at the time of screening, or are of child-bearing potential and do not practice medically acceptable methods of contraception. - Concurrent participation in another clinical trial using any investigational drug or device. - Patient suffers from a life threatening condition - Patients with history or clinical evidence of renal disease and/or previous clinically significant laboratory abnormalities of renal function parameters.
The purpose of this study is to assess the diagnostic value of microRNAs in IBD colon (ulcerative colitis or Crohn's disease) in adults as compared to healthy controls (and non-IBD colitis)
This is an open label exploratory study to investigate the safety of 400 milligram (mg ) twice a day (b.i.d.) GSK2586184 in patients with moderate to severe, active ulcerative colitis (UC). Study medication will be administered orally (as tablets), twice daily, for up to 8 weeks (56 days). Study medication will be taken with food. Each subject will have 6 out-patient visits: Screening (Day -30 to -1); Baseline and Start of treatment (Day 1); Week 2 (Day 14); Week 4 (Day 28); Week 8 (Day 56); and Follow-up (Week 12; Day 84). Visit windows for weeks 2, 4 and 8 will be + 2 days. The primary objective of this study is to assess the safety and tolerability of GSK2586184. The primary endpoints to measure safety are laboratory tests (including haematology, clinical chemistry and serum creatinine), vital signs, 12-lead electrocardiogram (ECG), physical examination, and adverse event reporting. These are standard measurements to evaluate safety.