View clinical trials related to Colitis.
Filter by: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.
The purpose of this study is to evaluate the accuracy of a subset of the length-109 probe set panel (a genetic test) in predicting response to golimumab treatment in participants with moderately to severely active ulcerative colitis (UC).
The incidence of C. difficile infection (CDI) has alarmingly increased over the past several years and the affected population has expanded to include those previously at low risk, such as children. The annual US financial burden associated with this infection is great and estimated to exceed $1.8 billion. C. difficile infection arises when the gut microbial ecology is disrupted during interventions notorious for perturbing the delicate microbial balance. A well known and common example is the use of antibiotics. Fecal microbiota transplant (FMT) has been introduced several decades ago in an attempt to restore the gut microbial balance. To this date there have been a great number of reports of success in eliminating recurrent C. difficile infections and restoring the gut microbial profile to resemble that of the healthy donor. While over 300 cases have been described in the literature, there has been no pediatric controlled studies performed to compare its efficacy to placebo. Therefore, there is a strong need to determine their safety and efficacy in pediatric randomized controlled studies. The investigators hypothesize that children with recurrent C. difficile infection will respond to fecal transplant therapy which will modify their gut microbial profile. The investigators propose a randomized, placebo controlled, pilot study of fecal microbial transplant in children with recurrent C. difficile infection to evaluate the safety and efficacy of fecal microbial transplant in children in preventing recurrent C. difficile infection. The investigators anticipate that fecal microbial transplant in children with recurrent C. difficile infection will be safe and efficacious and will provide these children with a great alternative to a disease that is difficult to treat. Results of this study will establish the major role of the gut microbiome in this disease and demonstrate the viability of gut microbial transplant in recipients.
The aim of this study is to a.) evaluate whether early serum infliximab levels are predictive of avoidance of colectomy, b) evaluate whether serum albumin levels correlate with serum infliximab levels, and c) evaluate whether serum tumor necrosis factor levels are inversely correlated with serum infliximab levels. In patients hospitalized for severe ulcerative colitis and treated with high-dose infliximab, we predict that early serum infliximab levels (24, 48, and 72 hour) will be positively associated with clinical response and avoidance of colectomy.
The purpose of the study is to develop, evaluate, and optimize an interactive website (the SMART portal). The SMART portal will use IBD-specific and general assessments and interventions to reduce the burden of common barriers to treatment adherence and enhance self-management skills. This study aims to build and revise the SMART portal according to feedback and testing from participants.
The purpose of this study is to find out whether a single fecal microbiota transplantation is an effective and safe treatment as an adjunct to standard therapy in patients with ulcerative colitis.
The purpose of this study of this study is to assess the responsiveness and validity of CIMS (Central Image Management System)-based endoscopic evaluation of UC (Ulcerative Colitis) clinical disease activity by measuring: The responsiveness central reader endoscopic EIs [(Endoscopic Indices) (MMCS (Modified Mayo Clinic endoscopy Subscore), UCEIS (Ulcerative Colitis Endoscopic Index of Severity) MBS (Modified Baron Score)] to clinical change from baseline to week 6 in a prospective trial of a treatment of known efficacy in UC.
The purpose of the study is to evaluate dose response of JNJ-54781532 in participants with moderately to severely active ulcerative colitis (UC).