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Ulcerative Colitis clinical trials

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NCT ID: NCT00803829 Completed - Ulcerative Colitis Clinical Trials

Synbiotic Treatment of Ulcerative Colitis Patients

Start date: January 2009
Phase: N/A
Study type: Interventional

Ulcerative colitis (UC) is one of the two main forms of inflammatory bowel disease. UC is associated with high morbidity and incurs significant social, commercial and NHS costs. For a variety of reasons, many patients are refractile to standard therapies, which often have undesirable side-effects. However, an inexpensive and non-toxic treatment based on the synbiotic concept may prove to be effective in these individuals. A synbiotic is a mixture of a probiotic (a live microorganism) and a prebiotic, which is a carbohydrate that serves as a food source for the probiotic, allowing it to grow better in the gut. The aim of this study is to determine whether a synbiotic comprised of fructooligosaccharides and inulin, together with a bifidobacterial probiotic (Bifidobacterium longum), that we have previously shown to reduce inflammatory processes in the gut wall (mucosa) in a short-term pilot trial, can colonise the bowel, reduce mucosal inflammation, and induce remission in UC patients with active disease. It is planned to establish a double-blinded, controlled, randomised investigation involving 46 patients for six months. If the results from our pilot study can be reproduced and maintained in a long-term investigation, the synbiotic could become available very quickly, and would provide an inexpensive and effective treatment for UC, making a significant contribution to relieving the clinical and financial burdens of this disease.

NCT ID: NCT00801723 Completed - Ulcerative Colitis Clinical Trials

(CB-01-02/04) Extension Study of Budesonide Multi-Matrix System (MMX) 6 mg in Maintenance Of Remission In Patients With Ulcerative Colitis.

Start date: December 2008
Phase: Phase 3
Study type: Interventional

Randomized, double-blind, comparative study versus placebo performed in patients from studies CB-01-02/01 (NCT00679432), CB-01-02/02 (NCT00679380), or CB-01-02/06 (NCT01100112) who achieved ulcerative colitis disease activity index (UCDAI) remission after 8 weeks of treatment. Patients in remission at the End of Study visit will be given the opportunity to enter the 12-month Maintenance Phase study outlined in this protocol (CB-01-02/04). The End of Study visit in studies 01, 02, and 06 will be set as the Visit 1 (Day 0) of this study. There will be no interruption of study treatment between the parent studies and this study. It is planned that approximately 150 patients will be enrolled in the study. Patients will be randomly assigned to two groups to receive either budesonide MMX 6 mg or placebo irrespective of the treatment assigned in studies 01, 02, or 06. Treatments will be administered once a day after breakfast for a maximum of 12 months or up to the occurrence of the first clinical relapse, where clinical relapse is defined as combined recurrence of rectal bleeding and stool frequency ≥ 1-2 stools/day above normal for the patient (score ≥ 1 in both UCDAI items). During the study, patients will be assessed for safety and efficacy at Visit 1 and after 1, 3, 6, 9, and 12 months of treatment. Patients will be contacted by telephone on a monthly basis for safety assessment. In case of occurrence of symptoms suggestive of clinical relapse, patients will attend an unscheduled visit at any time during the study.

NCT ID: NCT00798642 Completed - Ulcerative Colitis Clinical Trials

Ulcerative Colitis Relapse Prevention Trial, Hypnosis

UCRPT
Start date: July 2007
Phase: N/A
Study type: Interventional

The UCRPT is a randomized controlled trial to determine if a type of hypnotherapy will maintain remission in patients affected by Ulcerative Colitis.

NCT ID: NCT00793130 Recruiting - Ulcerative Colitis Clinical Trials

The Efficacy and Tolerability of Coltect as Add-on in Patients With Active Ulcerative Colitis - an Open Label

Start date: November 2008
Phase: N/A
Study type: Interventional

The aim of the study is to reduce the severity and duration of acute attacks, to prevent the recurrence of new acute attacks and to improve patient's quality of life. Coltect contains anti inflammatory and antioxidant natural agents (curcumin, green tea and selenomethionine) which are associated with a positive effect on inflammatory disease. The investigators assume that Coltect represents a tolerable and mild treatment, viable alternative to other medical therapies with fewer side effects. Coltect is a food supplement that contains active ingredients from herbal sources.

NCT ID: NCT00791557 Completed - Ulcerative Colitis Clinical Trials

Open Label Study for Adults With Pyoderma Gangrenosum and Inflammatory Bowel Disease

Start date: October 2008
Phase: N/A
Study type: Interventional

Subjects must be 18- 75 years old and have a history of both inflammatory bowels disease (Crohn's or ulcerative colitis) and pyoderma gangrenosum. This is a 6 month open label study of an intravenous (IV) medication. Visits occur every 2 weeks initially, then every 1-2 months later in the study.

NCT ID: NCT00790933 Completed - Ulcerative Colitis Clinical Trials

An Open-label Study of Vedolizumab (MLN0002) in Participants With Ulcerative Colitis and Crohn's Disease

GEMINI LTS
Start date: May 22, 2009
Phase: Phase 3
Study type: Interventional

The purpose of this multicenter, open-label study is to collect data on the occurrence of important clinical safety events resulting from chronic vedolizumab (MLN0002) administration.

NCT ID: NCT00790478 Terminated - Ulcerative Colitis Clinical Trials

Melatonin and Ulcerative Colitis: A Pilot Clinical Trial

Start date: January 2009
Phase: Phase 2
Study type: Interventional

Ulcerative colitis is an inflammatory bowel disease that afflicts up to one million people in the U.S. Symptoms include rectal urgency, bloody diarrhea, moderate to severe abdominal pain, fever, and fatigue. Melatonin is a hormone that is associated with sleep and other body functions that may be related to health. Melatonin is produced in the pineal gland and, in fact, it is produced in even greater amounts in the gut. Melatonin appears to be important in gastrointestinal tract physiology and health, and data from cell and animal experiments, and some studies in humans, suggest that supplemental melatonin may help ameliorate colitis. Given that current treatments for ulcerative colitis are not always effective, and often have serious side effects, there is considerable interest in finding alternative treatments for this disease. However, experimental data on the ability of melatonin to improve ulcerative colitis in humans are lacking. To address this, we plan to conduct a pilot clinical trial (60 adult male and female participants) that will obtain preliminary data about the effectiveness of melatonin supplementation as a treatment for ulcerative colitis in adult men and women with the disease. The "Melatonin and Ulcerative Colitis" study funded by a grant from the Broad Foundation's Broad Medical Research Program (http://www.broadmedical.org).

NCT ID: NCT00787202 Completed - Ulcerative Colitis Clinical Trials

A Study To Investigate The Safety And Efficacy Of CP- 690,550 In Patients With Moderate And Severe Ulcerative Colitis.

Start date: December 2008
Phase: Phase 2
Study type: Interventional

The hypothesis of the study is that at least one dose of CP 690 550 is superior to placebo (inactive drug) in inducing remission in patients with moderate to severe ulcerative colitis.

NCT ID: NCT00783718 Completed - Ulcerative Colitis Clinical Trials

Study of Vedolizumab (MLN0002) in Patients With Moderate to Severe Ulcerative Colitis

GEMINI I
Start date: January 2009
Phase: Phase 3
Study type: Interventional

The primary purpose of this study was to determine the effect of vedolizumab induction treatment on clinical response at 6 weeks and to determine the effect of vedolizumab maintenance treatment on clinical remission at 52 weeks.

NCT ID: NCT00783575 Withdrawn - Ulcerative Colitis Clinical Trials

Genetic Markers as Predictors of Phenotypes in Pediatric Onset Crohn's Disease

Start date: October 2002
Phase: N/A
Study type: Observational

The purpose of this study is to look for the NOD2 gene in children with Inflammatory Bowel Disease (IBD) and their parents. We hope to understand this NOD2 gene better by determining whether children that have IBD have the NOD2 gene. In those with the NOD2 gene, we want to see if the type of gene abnormality predicts the nature of their disease and if the genetic information helps doctors decide what therapies and/or treatments to use for their patients. We also hope to explore the relationships between known serologic markers of IBD (ASCA, pANCA, ompC) and the clinical characteristics and course of children with IBD. About 1500 children and as many of their parents as possible will take part in this study. Children who are newly diagnosed with IBD as well as children that are being seen in the Children's Health System are eligible to participate in this study. We are looking for children 18 years old or younger to participate. If possible, we would also like both parents of the child to participate.