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Colitis, Ulcerative clinical trials

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NCT ID: NCT00408629 Completed - Ulcerative Colitis Clinical Trials

Efficacy and Safety of Adalimumab in Subjects With Moderately to Severely Active Ulcerative Colitis

Start date: November 2006
Phase: Phase 3
Study type: Interventional

This was a Phase 3, multicenter, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of the human anti-tumor necrosis factor (TNF) monoclonal antibody adalimumab (ADA) in patients with moderately to severely active ulcerative colitis (UC).

NCT ID: NCT00408174 Completed - Ulcerative Colitis Clinical Trials

Balsalazide Disodium vs. Mesalamine in Mildly to Moderately Active Ulcerative Colitis

Start date: May 2006
Phase: Phase 3
Study type: Interventional

To establish the efficacy and safety of a new tablet formulation and dosing regimen of balsalazide disodium dosed twice daily in achieving clinical improvement in subjects with mildly to moderately active ulcerative colitis after 6 weeks of therapy.

NCT ID: NCT00403923 Completed - Ulcerative Colitis Clinical Trials

Amount of Lactose Causing Symptoms in People With Lactose Intolerance and Ulcerative Colitis

Start date: April 2007
Phase: Phase 0
Study type: Observational

The hypothesis underlying this study is that failure to recognise the role of lactose intolerance among patients with ulcerative colitis has led to inappropriate dietary advice and treatment with drugs that contain lactose as a filler. These failures exacerbate symptoms and lead to the unnecessary use of immune suppressant drugs. There is disagreement amongst researchers regarding the amount of lactose needed to cause symptoms in those who are lactose intolerance. The general consensus is that the amount of lactose in a glass of milk (12 grams) is enough to cause mild symptoms in most patients who are lactose intolerant (1). However, there have been a number of studies and case studies that argue that much lower amounts can cause symptoms (2, 3, 4, 5). This could be as little as 0.02 grams (6). Ulcerative colitis is a chronic relapsing inflammatory disease of the colon and rectum, characterised by recurrent episodes of abdominal pain and profuse diarrhoea. The prevalence of lactose intolerance in patients with ulcerative colitis is not greater than in the general population, but there is no evidence as to whether these patients are more sensitive to lactose. This study will identify the threshold at which symptoms of lactose intolerance develop in those who have both lactose intolerance and ulcerative colitis, to provide appropriate advice and treatment in the management of patients with these conditions.

NCT ID: NCT00385736 Completed - Ulcerative Colitis Clinical Trials

Efficacy and Safety of Adalimumab in Subjects With Moderately to Severely Acute Ulcerative Colitis

Start date: November 2006
Phase: Phase 3
Study type: Interventional

The objective of this study is to assess the efficacy and safety of adalimumab for the induction of clinical remission in subjects with moderately to severely active ulcerative colitis.

NCT ID: NCT00374725 Completed - Ulcerative Colitis Clinical Trials

Treatment of Ulcerative Colitis With a Combination of Lactobacillus Rhamnosus and Lactobacillus Acidophilus.

Start date: February 2003
Phase: N/A
Study type: Interventional

In this trial we test the hypothesis that a probiotic containing Lactobacillus acidophilus and Lactobacillus rhamnosus is an effective therapy for patients with ulcerative colitis.

NCT ID: NCT00366925 Completed - Ulcerative Colitis Clinical Trials

CESA 5.10 Investigation to Compare the Efficacy and Safety of the Adacolumn® Apheresis Device in Patients With Active Ulcerative Colitis

Start date: April 2006
Phase: N/A
Study type: Interventional

The purpose of this study is to compare the safety and efficacy of 5 Adacolumn® treatments over 5 weeks to 10 treatments (two Adacolumn® apheresis treatments during the first 2 weeks, followed by 6 weeks with one Adacolumn® apheresis treatment) in patients with active ulcerative colitis.

NCT ID: NCT00355602 Completed - Colitis, Ulcerative Clinical Trials

Antibiotics for the Treatment of Ulcerative Colitis

Start date: July 2006
Phase: N/A
Study type: Interventional

Ulcerative colitis (UC) is an acute and chronic inflammatory bowel disease, whose cause is unknown. However, it is widely accepted that bacteria living in the large bowel are essential for the development of the disease. Intuitively, therefore, a logical approach to treatment would be to use antibiotics. However, antimicrobial chemotherapy has been unsuccessful in managing acute colitis, and has had only limited benefit in long-term treatment. The failure of antibiotics in UC arises from the fact that no-one has tried to identify which bacteria are involved in causing disease, and equally importantly, nobody has targeted appropriate antibiotics to knock out the specific bacteria in question, in a systematic way. Despite this, increasing evidence implicates bacteria living on the lining of the bowel being involved in UC. Our aim, therefore is to identify bacteria colonizing the mucosal surface in the lower large intestine and to determine the antibiotic sensitivities of those the investigators believe to be particularly involved in the disease, such as enterococcit, peptostreptococci and enterobacteria. Because the investigators have already studied resistance to antimicrobial in many mucosal isolate, the investigators plan ot focus on using a combination of two antibiotics in this work. A controlled trial will test the benefit of using these antibiotics over a period of one month and then the patients will be followed up over a six month period. The investigators will be looking for significant long-term improvements, and a reduction in drug use following antibiotic therapy.

NCT ID: NCT00352404 Completed - Cancer Clinical Trials

Chromoscopic Guided Endomicroscpy to Diagnose Colitis Associated Dysplasia

Start date: August 2003
Phase: Phase 3
Study type: Interventional

Timely diagnosis of intraepithelial neoplasias (premalignant condition)is of crucial importance for clinical management of ulcerative colitis. We assessed the value of combined chromoscopy and endomicroscopy for diagnosis of intraepithelial neoplasias in a randomised controlled trial. Endomicroscopy is a new device which enables microscopy of the mucosal layer during ongoing colonoscopy. Chromoscopy means topical staining of mucosal surface to unmask areas of interest, which are subsequently examined with the endomicroscopic system.

NCT ID: NCT00350415 Completed - Ulcerative Colitis Clinical Trials

A Double Blind Study for the Treatment of Acute Ulcerative Colitis

Start date: June 2006
Phase: Phase 3
Study type: Interventional

A Double-blind, Randomized, 6-week, Parallel-group Design Clinical trial to assess the Safety and Efficacy of Asacol 4.8 g/day (800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mg mesalamine tablet) for the Treatment of Moderately Active Ulcerative Colitis (ASCEND III).

NCT ID: NCT00347048 Completed - Ulcerative Colitis Clinical Trials

Tacrolimus (FK506) Study in Moderate to Severe Refractory Ulcerative Colitis Patients

Start date: September 2006
Phase: Phase 3
Study type: Interventional

This study consists of a 2-week placebo-controlled double-blind inter-group efficacy study in moderate to severe refractory ulcerative colitis (UC) patients followed by a maximum of 12-week open-label efficacy and safety study in responders.