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Colitis, Ulcerative clinical trials

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NCT ID: NCT01037322 Completed - Ulcerative Colitis Clinical Trials

Cannabidiol for Inflammatory Bowel Disease

Start date: January 2010
Phase: Phase 1/Phase 2
Study type: Interventional

There are many anecdotal reports about improvement of Inflammatory bowel diseases (IBD) with cannabis smoking. The most effective anti inflammatory compound known today is cannabidiol. cannabidiol can be extracted from the cannabis plant, it has no central effect and is fat soluble so it can be given as drops in oil. Doses of up to 500mg did not cause any side effects. The aim of the proposed study is to examine in a double blind placebo controlled fashion the effect of cannabidiol on disease activity in patients with IBD.

NCT ID: NCT01036022 Completed - Colitis, Ulcerative Clinical Trials

Effect of GSK1399686 in Patients With Mild to Moderately Active Ulcerative Colitis

Start date: September 15, 2009
Phase: Phase 2
Study type: Interventional

This study is the first-time-in-patient trial of GSK1399686, a novel locally-acting anti-inflammatory compound, aimed at obtaining initial information on the tolerability, safety, pharmacokinetics (including concentrations in colon mucosa) and anti-inflammatory activity of GSK1399686 upon oral dosing in patients with active ulcerative colitis. The study is designed as a randomized, double-blind, double-dummy, placebo-controlled, sequential dose escalating trial, with an active control (ASACOL) group as internal control. Up to three cohorts (Cohorts 1-3), each consisting of approximately 20 patients with mild-moderately active ulcerative colitis not limited to the rectum, will be included, one for each dose level of GSK1399686 to be tested. Within a cohort, patients will be randomized in a 3:1:1 ratio to receive GSK1399686 (once daily over 4 weeks, followed by 2 weeks dosing with placebo), placebo, or ASACOL (t.i.d. for 6 weeks), respectively. An interim analysis of fecal markers and disease activity data will be performed by the end of Cohort 3. Based upon results, the study may be stopped or continued by recruiting either Cohort 4 (if data on an additional dose level would be warranted to establish or clarify a dose-response relationship) or, in the case of a robust efficacy signal at any dose level previously studied, Cohort 5 (to expand the sample size for given dose level in order to evaluate the efficacy of GSK1399686). The number of patients and randomization allocation ratio may be altered in Cohort 5 and it may not include an active control arm. If Cohort 4 is initiated upon interim analysis, then a second interim analysis may be performed at the end of Cohort 4, to assess whether progression into Cohort 5 (as defined above) would be justifiable.

NCT ID: NCT01033305 Completed - Clinical trials for Mild to Moderate Ulcerative Colitis

Oral Ciclosporin for Colonic Release in Ulcerative Colitis (CyCol™)

Start date: March 2010
Phase: Phase 2
Study type: Interventional

This is a multi-center study in Ireland and United Kingdom to determine the effects, safety and tolerability of a drug called CyCol™ in improving mild to moderate ulcerative colitis (UC). Informed consent will be obtained and following confirmation of eligibility and disease assessment, study participants will be randomised (allocated by chance) to take either CyCol™, or placebo, orally once every day for four weeks. Study visit assessments will include blood and stool tests, physical examinations and flexible sigmoidoscopies (inspection of the bowel wall using a flexible camera). Half the participants will receive CyCol™ and half will receive placebo. At the end of treatment (4 weeks) study participants will be reassessed again and the findings in those who received CyCol™ will be compared with those who received placebo. Any side effects experienced during the study and the safety of treatment with CyCol™ will also be evaluated.

NCT ID: NCT01032525 Completed - Ulcerative Colitis Clinical Trials

Monroe County Inflammatory Bowel Disease (IBD) Registry

Start date: January 1981
Phase: N/A
Study type: Observational

This phase is to register all subjects in Monroe County, New York with Inflammatory Bowel Disease (IBD) not already included to update the database for years 1990-2003. This will give us a truly population based study which will add to our knowledge of IBD epidemiology, allowing us to compare our rates with the rest of the world. We will be able to provide accurate incidence data from 1980 to 2000, and point prevalence from 12/31/2000. It will have special significance because of the relatively stable Monroe County population prior to 2000 (population in 1970=711,917; population in 2000 = 735,343).

NCT ID: NCT01026857 Completed - Ulcerative Colitis Clinical Trials

Propionyl-L-Carnitine in Ulcerative Colitis

Start date: May 2006
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether Propionyl-L-carnitine administration may ameliorate the illness in patients affected by mild to moderate ulcerative colitis already in treatment with one of the standard treatments (corticosteroids excluded).

NCT ID: NCT01020708 Completed - Ulcerative Colitis Clinical Trials

Study of the Safety and Tolerability of ALTH12 Versus Mesalamine Enema in Subjects With Left-Sided Ulcerative Colitis

Start date: November 2009
Phase: Phase 1
Study type: Interventional

This Phase I study will be a closely monitored trial of a small number of subjects to establish, preliminarily, the tolerability and safety of two ALTH12 enema formulations: ALTH12-1:4 and ALTH12-2:4. The study will be conducted in two parts. The first part will be the assessment of the safety and tolerability of a single dose of ALTH12-1:4 or the comparator, mesalamine (4.0g 5-ASA) followed by an assessment of repeated administrations of study drug (ALTH12-1:4 or comparator) for 6 weeks. The second part will be the same assessment for ALTH12-2:4. Three subjects will be enrolled in each cohort: 2 to receive ALTH12 enema therapy and 1 subject to receive comparator enema therapy. A total of up to 9 patients will be enrolled in this study, allowing for up to 3 replacement or additional patients.

NCT ID: NCT00963287 Completed - Ulcerative Colitis Clinical Trials

Trial of Chinese Prescription on Ulcerative Colitis

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

The purpose of this study is to evaluate the efficacy and safety of the Chinese prescription on Ulcerative Colitis.

NCT ID: NCT00961948 Completed - Ulcerative Colitis Clinical Trials

Indigo Carmine Staining and Narrow Band Imaging (NBI) of Colonic Mucosa for Detection of Dysplasia in Ulcerative Colitis

Start date: June 2009
Phase: N/A
Study type: Observational

A prospective, randomized trial to determine indigo carmine dye spraying and narrow band imaging (NBI) of colonic mucosa to detect dysplasia in ulcerative colitis (UC). Confocal laser microscopy may be beneficial in the further assessment of abnormalities identified by these methods.

NCT ID: NCT00951548 Completed - Ulcerative Colitis Clinical Trials

Food Supplementation With VSL#3 as a Support to Standard Pharmaceutical Therapy in Ulcerative Colitis

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

This is a double-blind, randomized, placebo controlled study to assess the beneficial effects of food supplementation with VSL#3 as a support to standard pharmaceutical therapy in patients affected by mild to moderate active ulcerative colitis.

NCT ID: NCT00940576 Completed - Ulcerative Colitis Clinical Trials

Dietetic Efficacy of Mare's Milk for Patients With Chronic Inflammatory Bowel Diseases

Start date: July 2000
Phase: N/A
Study type: Interventional

Mare's milk consumption could improve the well-being in patients with Crohn's disease and ulcerative colitis, respectively.