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Colitis, Ulcerative clinical trials

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NCT ID: NCT02092389 Terminated - Clinical trials for Moderate to Severe Ulcerative Colitis

Fecal Calprotectin Levels, QoL and Workability in Patients Suffering From Ulcerative Colitis Under Adalimumab Therapy - AdaProQuo

AdaProQuo
Start date: July 2014
Phase: N/A
Study type: Observational

The objectives of this study are to explore the effect of adalimumab on the fecal Calprotectin level of Ulcerative Colitis (UC) patients and the correlation with their general well-being (QoL), work ability and disease activity.

NCT ID: NCT02058524 Terminated - Ulcerative Colitis Clinical Trials

A Pilot and Feasibility Study of Fecal Microbiota Transplantation for Ulcerative Colitis

Start date: June 2013
Phase: Phase 1
Study type: Interventional

The investigators are conducting an open-label study of fecal microbiota transplantation (FMT) for adult patients with mildly-moderately active ulcerative colitis. In this pilot study the investigators will evaluate the feasibility, safety, and tolerability of a single application of FMT delivered colonoscopically. The investigators will also characterize the impact of FMT on the microbiota of the recipient and determine if it correlates with the microbiota from the FMT donor.

NCT ID: NCT02000453 Terminated - Colitis, Ulcerative Clinical Trials

Safety and Tolerability Study of GSK2586184 in Patients With Moderate to Severely Active Ulcerative Colitis.

Start date: December 20, 2013
Phase: Phase 1
Study type: Interventional

This is an open label exploratory study to investigate the safety of 400 milligram (mg ) twice a day (b.i.d.) GSK2586184 in patients with moderate to severe, active ulcerative colitis (UC). Study medication will be administered orally (as tablets), twice daily, for up to 8 weeks (56 days). Study medication will be taken with food. Each subject will have 6 out-patient visits: Screening (Day -30 to -1); Baseline and Start of treatment (Day 1); Week 2 (Day 14); Week 4 (Day 28); Week 8 (Day 56); and Follow-up (Week 12; Day 84). Visit windows for weeks 2, 4 and 8 will be + 2 days. The primary objective of this study is to assess the safety and tolerability of GSK2586184. The primary endpoints to measure safety are laboratory tests (including haematology, clinical chemistry and serum creatinine), vital signs, 12-lead electrocardiogram (ECG), physical examination, and adverse event reporting. These are standard measurements to evaluate safety.

NCT ID: NCT01960426 Terminated - Ulcerative Colitis Clinical Trials

Evaluation of Health Costs and Resource Utilization

Test-NoTest
Start date: April 2014
Phase: Phase 4
Study type: Interventional

Utilization of health resources in a testing based strategy versus an empiric dose escalation strategy to manage Crohn's disease and Ulcerative Colitis in subjects with loss of response to infliximab or adalimumab.

NCT ID: NCT01953354 Terminated - Colitis, Ulcerative Clinical Trials

Trichuris Suis Ova Treatment in Left-sided Ulcerative Colitis

Start date: November 2013
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and effectiveness of trichuris suis ova (TSO) in ulcerative colitis (UC). We will look at how TSO affects the body's immune response and if there are related changes in participants' UC.

NCT ID: NCT01882764 Terminated - Ulcerative Colitis Clinical Trials

HMPL-004 Maintenance Treatment in Subjects With Mild to Moderate Ulcerative Colitis

NATRUL-4
Start date: June 2013
Phase: Phase 3
Study type: Interventional

A study with an 8 week open label phase study followed by a year long placebo controlled maintenance phase in subjects with active mild to moderate ulcerative colitis (UC), with a modified Mayo Score 4-10 and an endoscopy subscore of 2-3, taking mesalamine (or equivalent) as a concomitant medication. Subjects are required to be in clinical remission or clinical response to enter the year long maintenance phase. This study will help evaluate if HMPL-004 is effective in subjects maintaining clinical remission following successful induction therapy achieving clinical remission or clinical response.

NCT ID: NCT01882426 Terminated - Ulcerative Colitis Clinical Trials

Care Path for the Management of Ulcerative Colitis

CONSTRUCT
Start date: May 2014
Phase: Phase 4
Study type: Interventional

Assess if standardized care-path that features objective evaluations of disease activity and time-bound algorithms is superior to usual step-care in the treatment of ulcerative colitis.

NCT ID: NCT01861249 Terminated - Ulcerative Colitis Clinical Trials

Long Term Safety And Tolerability Of SAR339658 In Patients With Ulcerative Colitis (UC)

Start date: July 2013
Phase: Phase 2
Study type: Interventional

Primary Objective: To assess the long term safety and tolerability of SAR339658 Secondary Objective: To assess the long term efficacy of SAR339658

NCT ID: NCT01805791 Terminated - Ulcerative Colitis Clinical Trials

A Phase III Trial of HMPL-004 in Patients With Mild to Moderate Active Ulcerative Colitis

Start date: March 2013
Phase: Phase 3
Study type: Interventional

A placebo controlled study of two doses of HMPL-004 in patients with active mild to moderate ulcerative colitis (UC), with a modified Mayo Score 4-10 and an endoscopy subscore of 2-3, taking mesalamine (or equivalent) as a concomitant medication. The objective is to evaluate the efficacy and safety of HMPL-004 with mesalamine (mesalamine treatment failures). Efficacy will be measured by a comparison of the proportion of patients in each treatment group attaining clinical remission at Week 8 as compared to placebo.

NCT ID: NCT01742754 Terminated - Ulcerative Colitis Clinical Trials

Fecal Microbiota Transplantation for Ulcerative Colitis

Start date: October 2012
Phase: N/A
Study type: Interventional

Fecal microbiota therapy (FMT) is an emerging treatment for gastrointestinal disorders marked by an imbalance in the intestinal microbial flora (dysbiosis). It is hypothesized to work by shifting the recipient's microbiota toward a eubiotic microbial community that resists colonization by pathogenic organisms or decreases its inherent inflammatory properties. Several studies now report its efficacy in treatment of severe Clostridium difficile colitis. Preliminary studies using FMT in Ulcerative Colitis (UC) have also met with some success. This is corroborated by several lines of evidence suggesting dysbiosis plays an important role in UC pathogenesis. While a recent study using FMT in patients with irritable bowel syndrome (IBS) and constipation found transplants persist for up to 2 years, the extent to which the microbiota is alterable in UC is not known. Indeed, there may be particular genetic or immunologic factors in UC leading to selection pressure preventing a change in the microbiota. As an initial step into investigating the potential efficacy of stool transplants for Ulcerative Colitis (UC), the investigators propose to determine the feasibility and stability of transplanted microbiota in a series of 10 patients with mild to moderate UC.