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Colitis, Ulcerative clinical trials

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NCT ID: NCT01860651 Completed - Ulcerative Colitis Clinical Trials

Web-based Monitoring in Children and Adolescents With Inflammatory Bowel Disease

Start date: September 2013
Phase: N/A
Study type: Interventional

The investigators hypothesize that E-health - web based monitoring of disease and treatment - in young patients with chronic inflammatory disease (IBD) can improve the disease course and quality of life. Adherence (to take the prescribed medicine) is difficult for young patients. In this E-health project the investigators seek to improve young patients (10-17 years) responsibility for treatment, to empower them and thereby enhance the adherence in order to achieve a more quiet disease course. Through the e-Health program and web-app the disease activity will be presented to the young patient via a simple traffic light chart and the patient will be guided to: continue the prescribed medication, call the physician or visit the out-patient clinic. In future the concept is believed also to be applicable for young patients with other chronic diseases.

NCT ID: NCT01852760 Completed - Ulcerative Colitis Clinical Trials

Assessment of Disease Activity in Ulcerative Colitis by Endoscopic Ultrasound

Start date: September 2013
Phase: N/A
Study type: Observational

In this cross-sectional study patients with active or quiescent ulcerative colitis will be studied to determine the utility of endoscopic ultrasound measurements of rectal wall blood flow and thickness as reliable indices of disease severity and the degree of correlation that exists with validated clinical, endoscopic, and histological indices.

NCT ID: NCT01839214 Completed - Ulcerative Colitis Clinical Trials

A Study to Evaluate the Efficacy and Safety of VB-201 in Patients With Ulcerative Colitis

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

This study will examine the safety and efficacy in subjects with mild to moderate ulcerative colitis, as measured by Modified Mayo Score, Modified Baron Score, IBDQ, calprotectin and other assessments.

NCT ID: NCT01837615 Completed - Ulcerative Colitis Clinical Trials

Assessment of Photopill Capsule Treatment for Safety and Feasibility in Ulcerative Proctitis

Photopill
Start date: January 2013
Phase: Phase 2
Study type: Interventional

Low Level Light therapy (LLLT) has been used for tissue healing in many mucosal diseases that involve wounds, ulcers and inflammation, oral chemotherapy-induced mucositis in particular. Likewise IBD is characterized by chronic tissue inflammation, tissue damage and ulcerations in various extents. Therefore we hypothesize that LLLT might be effective in treating IBD and the Photopill capsule was developed for this purpose. An open-label, interventional, clinical trial was designed for assessment of the safety and feasibilty of the Photopill capsule treatment in patients with mild to moderate Ulcerative Proctitis. Primary endpoints being: safety reflected by the number and severity of adverse events and mucosal appearance at sigmoidoscopies day 14, day 28, day 42 compared to baseline condition. Furthermore clinical and biochemical parameters are monitored during the study.

NCT ID: NCT01831427 Completed - Ulcerative Colitis Clinical Trials

Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of GS-5745 (Andecaliximab) in Adults With Moderate to Severe Active Ulcerative Colitis

Start date: March 28, 2013
Phase: Phase 1
Study type: Interventional

The primary objectives of this study are as follows: - To assess the safety and tolerability of escalating single and multiple doses of GS-5745 (andecaliximab) in participants with moderate to severe ulcerative colitis (UC) as assessed by adverse events (AEs) and laboratory abnormalities - To assess the pharmacokinetics (PK) of GS-5745 (andecaliximab) in participants with moderate to severe UC.

NCT ID: NCT01829321 Completed - Ulcerative Colitis Clinical Trials

Safety, Efficacy, Pharmacokinetic and Pharmacodynamic Study of GLPG0974 in Subjects With Ulcerative Colitis

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

- Approximately 45 patients suffering from mild to moderate ulcerative colitis will be examined for any side effects (safety and tolerability) that may occur when taking GLPG0974 or matching placebo (2:1 ratio) for 28 days. - During the course of the study, patients will also be evaluated for improvement of disease activity by different efficacy measures, the amount of GLPG0974 present in the blood determined (PK) and the effects of GLPG0974 on selected biomarkers (PD) in the blood, colon biopsies and faeces will be explored.

NCT ID: NCT01813500 Completed - Ulcerative Colitis Clinical Trials

Host Immune Response to Clostridium Difficile Infection in Inflammatory Bowel Disease Patients

Start date: October 2011
Phase: N/A
Study type: Observational

The inflammatory bowel diseases (IBD), ulcerative colitis (UC) and Crohn's disease (CD) are chronic conditions affecting approximately 1.4 million Americans. The burden of Clostridium difficile infection (CDI), a frequent cause of infectious diarrhea is mediated by toxins A and B and is increasing faster in IBD patients, than the general population. Clinically, CDI in patients with IBD leads to a range of clinical syndromes from symptomless carriage, to severe life threatening colitis, colectomy and death. This pilot study will look at the relationship between IBD and this variable host immune response. Clostridium difficile colonization (asymptomatic carrier state) is lower in the IBD population than in the general population. In the general population, high antitoxin titers have been linked with colonization and low antitoxin titers with recurrent disease. The investigators hypothesize that patients with IBD will have a lower Clostridium difficile colonization and will have lower antibody titers than the control group. Additionally those with lower titers will have an increased risk of developing CDI. In Aim 1 the investigators will determine Clostridium colonization in IBD subjects by stool study (including CD, UC and UC patients after IPAA) compared to non-IBD subjects (controls). In Aim 2 the investigators will compare antitoxin titers in these IBD subjects compared to controls. In Aim 3 the investigators will follow these subjects for 12 months and calculate the incidence of CDI in patients with IBD compared to controls and associations with anti-toxin titers.

NCT ID: NCT01804166 Completed - Clinical trials for Hepatosplenic T-Cell Lymphoma

A Research Study to Bank Samples for Future Evaluation to Identify Biomarkers That Predispose Crohn's Disease and Ulcerative Colitis Patients to Develop Hepatosplenic T-Cell Lymphoma (HSTCL)

Start date: March 21, 2013
Phase: Phase 4
Study type: Interventional

This study is designed to collect tissue samples from the biopsy specimen that was used to diagnose hepatosplenic T-cell lymphoma (HSTCL), additional patient information, and if possible, to obtain additional samples including a single blood sample, a buccal swab sample and/or a bowel tissue sample. Samples obtained will be stored by the sponsor for future testing. In addition, demographic and clinical patient information will be collected. The study will be conducted in North America. Patients eligible for enrollment include males or females with IBD of any age who have a confirmed diagnosis of HSTCL. Patients will be identified through the sponsor's adverse event reporting systems. Cases reported to the sponsor's Medical Information Center will be queried to ascertain if the reporter is interested in participating in the study. Where appropriate, cases may also be identified through the sponsor's new or on-going clinical trials and registries. Samples may be collected from living patients or from stored tissue of deceased patients. This study will not restrict or introduce any therapeutic interventions, including medications. All patients will continue to be managed by their personal physicians. No healthy subjects will be enrolled in this study.

NCT ID: NCT01798953 Completed - Ulcerative Colitis Clinical Trials

Surgical Reconstruction in Ulcerative Colitis With Primary Sclerosing Cholangitis

Start date: January 2010
Phase: N/A
Study type: Observational

Primary sclerosing cholangitis (PSC) occurs in approximately 10 % of patients with ulcerative colitis (UC), but the outcome of reconstructive surgery is not clear. The purpose of this study was to determine the functional outcome after surgery, frequency of pouchitis, complications and failure-rate in UC-PSC patients compared to patients with UC alone. Both ileal pouch-anal anastomosis (IPAA) and ileo-rectal anastomosis (IRA) were studied.

NCT ID: NCT01772615 Completed - Ulcerative Colitis Clinical Trials

Treatment of Ulcerative Colitis With Ciprofloxacin and E. Coli Nissle

Start date: May 2011
Phase: Phase 4
Study type: Interventional

Purpose: The purpose of the study is to investigate if treatment with ciprofloxacin for one week followed by therapy with E. Coli Nissle (EcN) for seven weeks can influence disease activity among ulcerative colitis patients with disease flare-ups compared to placebo controls.