Active clinical trials for "Crohn Disease"

The purpose of this study is to characterize which patients with Crohn's disease are likely to respond to standard of care to vedolizumab therapy.

We will quantify one of the lipid compounds (5,6 epoxy eicosatrienoic acid (5,6 EET), 5,6- EpoxyEicosaTrienoic acid) in colonic biopsies of Inflammatory Bowel Disease patients. We will evaluate its possible use as a pathological activity biomarker and its potential as a therapeutic target. We hypothesized that 5,6-EET is present in human colonic tissues in varying quantities depending on the pathological state of the IBD patient.

We would like to collaborate and further develop an ipad-based, interactive quiz game 'Emma'; to identify gaps in knowledge of inflammatory bowel disease in pediatric patients. These gaps can be used to improve patient education.

Inflammatory bowel disease (IBD) encompasses two major forms of chronic intestinal disorders, Crohn's disease and ulcerative colitis (UC). Diagnosis is based on several macroscopic and histologic features including patterns of inflammation, crypt abscesses and granulomas. i-Scan use an endoscopic image from the video processor and reconstruct virtual images in real time, resulting in an improved contrast of the capillary patterns and enhancement of the mucosal surface (so called virtual chromoendoscopy). The main objective of this study is to determine endoscopic features of mucosal healing in patients with IBD and to compare these features to clinical and histological data in order to establish a new endoscopic classification of mucosal healing and to evaluate mucosal healing as a parameter of remission and relapse.

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.

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.

This multicenter, prospective, post marketing observational study (PMOS) was designed to demonstrate long-term effects of anti-Tumor Necrosis Factor therapies on Work Productivity and Impairment scales in participants with moderate to severe Crohn's Disease (CD) under routine conditions. Secondary objectives of this study were long-term improvement of Quality of Life (QoL), evaluation of improvement of extraintestinal symptoms and comorbidities, and evaluation of safety.

Study Hypothesis: It is estimated that by re-programming some of the PillCam COLON2 system parameters it can serve as tool for visualizing both small bowel and colon. As such, the system may be utilized in CD patients for monitoring mucosal healing. Primary objectives: To evaluate two different video output methods in the visualization of the SB and colon in CD patients Secondary objectives: Evaluate the level of agreement between PillCam system and ileocolonoscopy on the assessment of CD findings. Evaluate the effectiveness of PillCam regimen in CD patients Inclusion criteria Patient is 18 years of age and above Patient with a diagnosis of ileocolonic or colonic Crohn's Disease documented by endoscopical, histopathological and/or radiological parameters Patients' CDAI >150. Patient is clinically indicated to undergo ileocolonoscopy for assessment of Crohn's disease Proven patency by Agile capsule or another approach deemed clinically acceptable by the investigator, e.g. CT enterography, performed within the 3 months prior to enrollment Patient is able and agrees to sign the Informed Consent Form Exclusion criteria Patient has dysphagia Patient has congestive heart failure Patient has renal insufficiency Patient has cirrhosis Patient is known or is suspected to suffer from intestinal obstruction Patient has known previous stricture/obstruction of the SB or colon Patient has taken NSAID medications less than one month before enrollment Patient suffers from hypertension and is taking one or more of the following medications used for control of hypertension: diuretics, ACE inhibitors, Angiotensin II blockers Chronic use of laxatives Patient has a cardiac pacemakers or other implanted electro medical devices. Women who are either pregnant or nursing at the time of screening, who intend to be during the study period, or are of child-bearing potential and do not practice medically acceptable methods of contraception. Patient is expected to undergo MRI examination within 7 days after ingestion of the capsule. Patient has had prior abdominal surgery of the gastrointestinal tract other than uncomplicated procedures that would be unlikely to lead to bowel obstruction based on the clinical judgment of the investigator. Patient has any condition, which precludes compliance with study and/or device instructions. Patient suffers from life threatening conditions Patient is currently participating in another clinical study Patient has known slow gastric emptying time Patient is allergic or contraindicated to any of the study medications

The study aims at showing that the susceptibility in the stress is more raised at the person affected digestive pathologies (SII or IBD) in forgiveness than healthy subjects.

Background and Rationale: Inflammatory bowel disease (IBD) is a major burden to individuals and society. Ulcerative colitis and Crohn's disease (CD) are the 2 major inflammatory bowel diseases (IBD). They share some pathologic and clinical features but overall their pathogenesis is not resolved and diagnosis is sometimes difficult. The incidence rates range from 3.1 to 14.6 cases per 100,000 person year for Crohn's disease to 2.2 to 14.3 cases per 100,000 person years for ulcerative colitis and prevalence ranges up to 201/100,000 for Crohn's disease and up to 246/100,000 persons for ulcerative colitis. Powerful biological therapies were recently introduced for the treatment of CD. They offer superior treatment for the treatment of steroid refractory patients. Interestingly newer studies suggest that these therapies might also be beneficial if not superior if used at earlier stages of the disease. But presently limitations of these treatments need to be considered and biomarkers that could better direct these treatments are urgently needed. One present limitation is that these new therapies, though being beneficial in a large number of CD patients, will not be beneficial to all CD patients. Presently treatment responders and non-responders can not be identified prior to the treatment with the biological adalimumab representing an important unmet clinical need. Since adalimumab treatment can be accompanied by serious, potentially lethal, side effects, it would be a major advantage if future biomarkers could predict whether an individual will or will not respond to one or the other treatment. Furthermore with treatments available being associated with high costs to patients and society, as the treatment with adalimumab is, biomarkers that would help to identify potential treatment-responders or non-responders would support their targeted use and would be appreciated by all stakeholders. Nuclear magnetic resonance (NMR) spectroscopy is a method that generates comprehensive metabolic profiles from human biofluids, and these metabolomic profiles may be useful to identify biomarkers with discriminative and predictive power in CD. Thereby amongst other factors serum metabolites are affected by inflammation and urine metabolites are affected by gut flora and thus one or a combination of both may be a valuable tool in CD. Aim: The investigators aim is to identify metabolomic predictors of clinical response to adalimumab treatment in CD patients in order to direct future treatment to a group of patients that is expected to benefit most. Methods: Metabolomic profiling together with the collection of clinical data will be performed in patients with IBD prior to treatment with biological therapy and for up to 6 month thereafter. In the study the investigators follow 50 patients with Crohn's Disease, naive to treatment with biologics. Metabolomic profiling will be performed 1 week prior to the treatment with adalimumab and then every 4 weeks for 6 month. In order to be reliable and reproducible, sampling will be performed in the morning after an overnight fasting period. On the days of serum/urine collection the following data will be collected: CBC, ESR, CRP, Calprotectin, ASCA/pANCA, IL-10, TNFα, IFNγ, Crohn's disease Activity Index, present medication and OTC, Dietary and lifestyle history including 24 hour dietary recall, alcohol intake, smoking and exercise. Multivariate analysis will be performed to identify patterns in the metabolomic profile that predict response or non-response to adalimumab treatment. To summarize, IBD is a major burden to patients and society. Adalimumab treatment is helpful in steroid refractory patients. Novel biomarkers that help physicians to decide which patient might benefit from adalimumab treatment may be powerful tools to optimize directing these powerful but expensive and side effect bearing therapies towards the patient that might benefit most. Metabolomic profiling may be the tool that helps us to identify these patients.