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Colitis, Ulcerative clinical trials

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NCT ID: NCT01861288 Completed - Ulcerative Colitis Clinical Trials

Deep Endoscopic Remission Assessed by a Surrogate Biomarker in Patients With Inflammatory Bowel Disease

Start date: November 1, 2013
Phase:
Study type: Observational

We hypothesize that the number of needed endoscopic procedure performed at IBD patients (adult and children), can be reduced by using an individualized algorithm of symptoms, blood and faecal biomarkers. The aim of the study is to reduce the numbers of endoscopies, as the procedure is uncomfortable for the patient, time consuming and expensive. Through indirect tests - blood test, fecal inflammation marker and clinical symptoms - compared to endoscopic findings, we want to construct an algorithm by which the intestinal healing can be foreseen without performing an endoscopy. Furthermore, we will correlate FC, blood tests, clinical symptom score and endoscopic score, with the histo-pathological inflammation score from intestinal biopsies and the immunological score depicted by TNF- alpha and IL17A levels in intestinal tissue, in order to assess the gold standard - endoscopic remission.

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: 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: NCT01848561 Active, not recruiting - Clinical trials for Ulcerative Colitis (UC)

A Long-Term Registry of Humira® (Adalimumab) in Patients With Moderately to Severely Active Ulcerative Colitis (UC)

Start date: April 29, 2013
Phase:
Study type: Observational

This is a registry study to evaluate the long-term safety and effectiveness of adalimumab in patients with moderately to severely active UC who are treated as recommended in the product label.

NCT ID: NCT01846026 Withdrawn - Ulcerative Colitis Clinical Trials

Ulcerative Colitis and Vitamin D Supplementation

Start date: April 2013
Phase: Phase 1/Phase 2
Study type: Interventional

Ulcerative colitis (UC) is an inflammatory disease involving the colonic mucosa, with bleedings and ulcerations. Consequences are destroyed mucosal barrier and increased permeability. Several cytokines are described to mediate the progressive course of ulcerative colitis and it is considered nowadays an immunologic disease. Patients with UC have often low levels of vitamin D and elevated prevalence of osteoporosis. In vitro studies demonstrate that vitamin D has an immunomodulating effect, and may have a direct healing action on colonic mucosa has been described in animal studies. One can therefore rise a hypothesis that vitamin D supplementation could be crucial in patients with UC. To our knowledge, it has not been performed randomized clinical trials to study these possible effects of vitamin D and it has not been studied the effects of vitamin D on the relapse frequency and immunological composition of colic mucosa in patient with moderate to severe ulcerative colitis. Objectives for our study are as follows: To examine if high-dose vitamin D supplementation in patients with moderate to severe ulcerative colitis: - reduces relapse frequency and increase the duration of the Infliximab induced remission - mediates and changes the cytokines composition in the colic mucosa - decreases the excretion of calprotectin in feces and reduces the concentration of inflammation markers - augments bone mass

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.