Clinical Trials Logo

Ulcerative Colitis clinical trials

View clinical trials related to Ulcerative Colitis.

Filter by:

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: 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: 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: NCT00781638 Completed - Ulcerative Colitis Clinical Trials

ADAPT Adacolumn Pediatric Trial in Ulcerative Colitis

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

Children aged up to 18 years with moderately active Ulcerative Colitis (PUCAI:35-64) will receive one weekly Adacolumn® apheresis treatment over 5 consecutive weeks, followed by up to 3 optional Adacolumn® apheresis treatments over 3 consecutive weeks. Primary end point is PUCAI at Week 12. The main part of the clinical investigation will be continued by a one year follow up for responders.

NCT ID: NCT00780507 Completed - Ulcerative Colitis Clinical Trials

Fecal Biomarker Study for Patients With Ulcerative Colitis

Start date: August 2007
Phase: Phase 3
Study type: Observational

The present study will analyze fecal levels of FC and FL in UC patients who relapse (flare) while on a QD or a BID Asacol treatment regimen and compare those levels to levels of FC and FL in UC patients who do not relapse (flare).

NCT ID: NCT00769353 Completed - Depression Clinical Trials

Understanding and Treating Neuropsychiatric Symptoms of Pediatric Physical Illness

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

This research will examine the impact of brain activity, cognitive processing immune functioning, and gastrointestinal functioning on depressive symptoms and response to a psychotherapeutic intervention in youths with Inflammatory Bowel Disease (IBD).