View clinical trials related to Colitis, Ulcerative.
Filter by:PHASE: IV TYPE OF STUDY: With direct benefit DESCRIPTIVE: multicenter, open-label, uncontrolled trial INCLUSION CRITERIA: Adults with moderate to severe ulcerative colitis who failed corticosteroids and immunosupressive therapy, or are intolerant to immunosuppressors. All included patients will be naïve to anti-TNF therapy. Active disease at golimumab treatment initiation defined as a MAYO score ≥6 and with an endoscopic sub score ≥2. OBJECTIVE: To determine the proportion of patients with Continuous Clinical Response (CCR) and endoscopic remission after one year of golumimab at week 54. STUDY DESIGN: Induction Phase : Week 0: golimumab 200mg- Week 2: golimumab 100 mg- Week 6: golimumab 50 mg Maintenance Phase I : Week 10-Week 54 Week 10-Week 54 • Patients with primary clinical response*: Standard regimen with golimumab 50 mg Q4W (or 100 mg Q4W if > 80 kg) - Patients without primary clinical response at week 10 or with flare between week 10-week 54*: Optimization to 100 mg Q4W (or combination therapy with azathioprine if > 80 kg or switch from azathioprine to methotrexate if already on azathioprine at golimumab initiation or patient with known intolerance to thiopurines) - Early escape at Week 18: Primary non-responders who are still not responding at week 18 to dose optimization at Weeks 10 and 14 will be considered treatment failures and will be followed up (call or visit) at week 54 for safety. - Clinical response is defined as a decrease from baseline in the Mayo score ≥30% and ≥3 points, accompanied by either a rectal bleeding sub score of 0 or 1 or a decrease from baseline in the rectal bleeding sub score ≥1 Intermittent Phase II : Week 54-Week 108 • Patients with CCR and MH at week 54 and on golimumab 50 mg every 4 weeks: Stop golimumab and continuation of thiopurines or methotrexate if on combination therapy • Patients with CCR and MH at week 54 and on golimumab 100 mg every 4 weeks: De-escalation to 50 mg every 4 weeks and continuation of thiopurines or methotrexate if on combination therapy • Restart/Escalate golimumab on flare (defined in section 4 of the protocol) to the phase I dose; 50 mg q4wk or 100mg q4wk (similar to the phase I regimen)
Vedolizumab is a new medication being used for the treatment of Crohn's disease and Ulcerative colitis. It works by blocking specific white blood cells (alpha 4-beta7 lymphocytes) from migrating to areas of inflammation in the gastrointestinal tract. Previous studies have shown that patients who have previous exposure to another type of medication for Crohn's disease and Ulcerative colitis (anti-TNF medications) do not respond to vedolizumab as well as those who have never been exposed. This study will investigate biologic markers in the blood and tissue the help identify possible reasons for this difference.
The daily requirement of threonine, an essential amino acid, will be evaluated in healthy adult males and in adult males with Crohn's Disease or ulcerative colitis using the indicator amino acid oxidation (IAAO) method. Participants will consume specially formulated diets with varying levels of threonine.
The purpose of this study is to evaluate the efficacy and safety of ustekinumab as intravenous (IV: into the vein) infusion in induction study in participants with moderately to severely active Ulcerative Colitis (UC) and as subcutaneous (SC) administration in maintenance study in participants with moderately to severely active Ulcerative Colitis (UC) who have demonstrated a clinical response to Induction treatment with IV ustekinumab.
Mucosal immunology during helminth infection
The anticipated advantages of 3D laparoscopic visualization for the surgeon are greater accuracy and speed in manual skills, translating to decreased operative time, reduced learning curve, and superior safety.We aimed to determine the feasibility of the laparoscopic approach using 3D visualization in the surgical treatment of ulcerative colitis
This national, observational and multicentre study aims at establishing a picture of real clinical practices management among patients treated with Pentasa®, according to the current therapeutic strategy in proctitis or distal proctosigmoiditis. This study should be able to provide data on patients' health related quality of life, compliance and efficacy in real clinical practice
The purpose of this study is to investigate the efficacy and safety of 4-week double-blind treatment with PENTASA enema compared with placebo enema in Chinese patients with mild to moderate active left-sided ulcerative colitis, followed by a maximal 28-week open-label extension phase with PENTASA enema and/or PENTASA tablets.
This randomized, pilot phase I trial studies the side effects of berberine chloride in treating patients with ulcerative colitis and who are in remission (a decrease in or disappearance of signs and symptoms of cancer) to reduce the risk of colorectal cancer. Patients with ulcerative colitis are at increased risk for colorectal cancer. Chemoprevention is the use of drugs, such as berberine chloride, to keep a disease/condition from forming or coming back. The use of berberine chloride may keep colorectal cancer from forming in patients with ulcerative colitis.
The goal of the study is to evaluate strategies that target the microbiota for the treatment of Ulcerative Colitis , This study will involve a novel diet that the investigators developed , based on the hypothesis that UC involves dysbiosis , underutilzation of certain metabolic pathways and use of pathways that increase risk of inflammation . The investigators have postulated that manipulation of colonic bacterial metabolism with this diet will induce remission in UC without involving additional immune suppression.