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Ulcerative Colitis clinical trials

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NCT ID: NCT02277470 Recruiting - Ulcerative Colitis Clinical Trials

Study of the Pharmacokinetics of Golimumab in Moderate to Severe Ulcerative Colitis

GO-KINETIC
Start date: August 2014
Phase: N/A
Study type: Observational

The purpose of this study is to gain insights in the pharmacokinetics of golimumab in moderate to severe Ulcerative Colitis after subcutaneous administration, during induction and maintenance treatment the investigators will collect blood and stool samples at different time points.

NCT ID: NCT02264275 Recruiting - Depression Clinical Trials

Influence of Aerobic Exercise Training (AET) on Inflammatory Bowel Disease (IBD) in Children and Adolescents

Ex-CED
Start date: October 2014
Phase: N/A
Study type: Interventional

The purpose of this study is to determine if aerobic exercise training can serve as comprehensive palliative care, whereby enhancing cardiovascular fitness, mitigating depressive symptoms and augmenting sleep while bolstering health related quality of life in youth with Crohn's Disease and Ulcerative Colitis.

NCT ID: NCT02186886 Recruiting - Ulcerative Colitis Clinical Trials

Physiological Intermolecular Modification Spectroscopy (PIMS) in Ulcerative Colitis With Golimumab

Start date: June 2014
Phase: Phase 4
Study type: Interventional

Aim of this study is to determine wether the macromolecular spectral characteristic of ulcerative colitis patients - measured by Physiological Intermolecular Modification Spectroscopy (PIMS) - is a predictive factor for response to Simponi treatment

NCT ID: NCT02130349 Recruiting - Ulcerative Colitis Clinical Trials

IBDSL Biobank Project. Molecular Markers for Diagnosis and Therapy Response in IBD.

IBDSL
Start date: February 2011
Phase: N/A
Study type: Observational [Patient Registry]

The IBD South Limburg (IBDSL) project was initially designed as a prospective population based cohort study. Since 1991, all new IBD cases have been enrolled in the cohort and prospectively followed. As from 2011, the cohort is being scaled up into a population based biobank and focus expanded from epidemiology towards exploring underlying biologic mechanisms and identifying markers to predict disease course or therapy response. Every adult IBD patient, diagnosed in and permanently residing in South Limburg (The Netherlands), is eligible to participate. The population based nature was reached via a multi-faceted approach; incident cases were prospectively identified through the participating hospitals, and missed patients were retrospectively identified using the nationwide histopathology registry. In 2011, over 3500 patients were included, which represents 93% of the IBD population in South Limburg. The cohort includes baseline data, such as IBD phenotype, extent, location, behaviour, extra intestinal manifestations, medication, surgery, comorbidity and demographics. Data has prospectively been updated through chart review (clinical data), questionnaires (i.e. quality of life) and linkage to the authority database (vital state, residence). The biobank includes serum, plasma, DNA, faeces, biopsies and exhaled air. We welcome new collaborations. Applications for collaboration are first to be approved by our IBD-SL committee.

NCT ID: NCT02066272 Recruiting - Ulcerative Colitis Clinical Trials

Safety of Anti-tumor Necrosis Factor (TNF) Monoclonal Antibodies in Inflammatory Bowel Disease

SATIMOS
Start date: January 2014
Phase: N/A
Study type: Observational [Patient Registry]

Anti-TNF (tumor necrosis factor) monoclonal antibodies have revolutionized management of Inflammatory bowel disease. Their common features include high efficacy but also immunogenicity and increased infection risk. Since 2013, two generics or biosimilars of the first anti-TNF have been registered in Europe, which long lerm safety profile needs yet to be established. This prospective, multicenter, observational cohort study will assess safety of treatment of anti-TNF monoclonal antibodies in inflammatory bowel disease patients in Poland. Eligible are consecutive patients in whom anti-TNF is started for Crohn's disease, ulcerative colitis or indeterminate colitis between January 1st, 2014 and December 31st, 2015. Data to be collected include demography, Montreal classification, indication to treatment, previous treatment, operations, extraintestinal manifestations and concomitant diseases. Data on response, tolerability and safety of anti-TNF and on concomitant treatment will be collected. Adverse events logs will be completed. Majority of IBD centres in Poland, pediatric and adult, academic and regional, have agreed to participate in the study. As a result of the study, the frequency of adverse events in a cohort of Polish IBD patients on various anti-TNFs will be established.

NCT ID: NCT01914887 Recruiting - Ulcerative Colitis Clinical Trials

Allogeneic Adipose Tissue-derived Mesenchymal Stem Cells for the Induction of Remission in Ulcerative Colitis

ALOASCU
Start date: June 2013
Phase: Phase 1/Phase 2
Study type: Interventional

The aims of our study are to evaluate the feasibility and safety of endoscopic injection of adipose tissue-derived mesenchymal stem cells in human subjects with moderate active ulcerative colitis, assessing the absence of adverse events associated to the investigational drug, and to evaluate the efficacy of the treatment to induce remission of moderate active ulcerative colitis, by improvements in disease activity index, quality of life index, and endoscopic index.

NCT ID: NCT01882205 Recruiting - Ulcerative Colitis Clinical Trials

Comparison Between Chromoendoscopy and Virtual Chromoendoscopy (NBI, I-scan, FICE) for Detection of Neoplasia in Long Standing Ulcerative Colitis

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

The risk for colon cancer in patients with longstanding ulcerative colitis exceeding the rectum is increased and therefore patients should be enrolled in a surveillance program eight years after the diagnosis. Until today, official international guidelines for endoscopic screening in patients with ulcerative colitis advise to take 4 biopsies every 10 centimeters (with a minimum of 32) and of each suspected visible lesion. These guidelines are merely based on consensus during expert opinion meetings rather than evidence based. Recent studies have shown that chromo-endoscopy guided biopsies significantly reduced the number of biopsies for each procedure and detected more neoplastic lesions. Chromo-endoscopy is therefore considered the gold standard in this study in which we want to compare it to the performance and efficiency of new endoscopic imaging techniques. Narrow-Band Imaging (NBI) selectively uses certain wavelengths of the visible light leading to a shift in the excitation spectrum towards blue light. The first studies with NBI showed that the additional value of NBI in the detection of neoplastic lesions is comparable to chromo-endoscopy, but time saving and easier to perform. The Fujinon Intelligent Chromo-Endoscopy (FICE) system uses a similar theoretical principal as NBI but this is achieved via the use of post hoc computer algorithms, applying different filters to the stored endoscopic images and enabling a theoretically endless number of combinations of filters that can be used. The Pentax I-scan system also allows post hoc modification of the images. On the one hand, surface enhancement enables to better highlight mucosal changes. Spectral modification allows to apply different modes in analogy with to FICE system. These new imaging techniques have a theoretical advantage which is extendedly used for sales purposes but has however so far not been proven in ulcerative colitis patients. We want to test their clinical use in the screening for neoplastic lesions in patients with long standing ulcerative colitis.

NCT ID: NCT01790061 Recruiting - Ulcerative Colitis Clinical Trials

Standardized Fecal Microbiota Transplantation for Ulcerative Colitis

Start date: February 2013
Phase: Phase 2/Phase 3
Study type: Interventional

The gut microbiota is considered to constitute a "microbial organ" which has pivotal roles in the intestinal diseases and body's metabolism. Evidence from animal and human studies strongly supports the link between intestinal bacteria and inflammatory bowel diseases (IBD). Dozens of studies reported its efficacy in treatment of severe Clostridium difficile colitis. Preliminary studies using FMT for Ulcerative Colitis (UC), Crohn's diseases, irritable bowel syndrome (IBS) and constipation have also met with some success. This is an initial step into investigating the potential efficacy of standardized fecal bacteriotherapy through mid-gut (at least below duodenal papilla) for UC, the investigators propose to determine the efficiency and safety of FMT in a series of 500 patients with moderate to severe UC (Montreal classification).

NCT ID: NCT01783119 Recruiting - Ulcerative Colitis Clinical Trials

Effect of Aloe Vera in the Inflammation of Patients With Mild Ulcerative Colitis

AVIUC
Start date: August 2012
Phase: Phase 0
Study type: Interventional

The Ulcerative Colitis (UC) belongs to the group of diseases called Inflammatory Bowel Disease (IBD) which is characterized by a chronic ulceration of the colon. The conventional treatment can have adverse effects and does not guarantee effectiveness in some patients requiring aggressive therapy using adjuvant therapy Aloe vera has been shown to have a beneficial effect in different disease, and have an anti-inflammatory effect in UC patients. Objective: Measuring the effect of the consumption of 200 ml of aloe vera gel daily for a period of three months, in the degree of inflammation in patients with mild UC based on Mayo scale and quantification of IL-6 in the colonic mucosa.

NCT ID: NCT01771224 Recruiting - Ulcerative Colitis Clinical Trials

Effect of FAn-7 in UC Activity

FAUC
Start date: January 2013
Phase: Phase 0
Study type: Interventional

Introduction: Inflammatory bowel disease (IBD) refers to two chronic diseases that cause intestinal inflammation, ulcerative colitis (UC) and Crohn's disease (CD). The conventional treatment is not effective; therefore, alternative therapies may be effective specially in UC patients. Fatty acid (FA) may have a beneficial effect on some UC patients. The increasing incidence and prevalence of UC and ineffective treatments in some patients, allows search coadjuvant therapies. Objective: Quantification of differences between patients with and without FA. Methods: In two groups of patients with UC is administered FA and placebo. We will measure the changes clinical, endoscopic and histological in both groups, before and after treatment.