Active clinical trials for "Crohn Disease"

RATIONALE: A substantial proportion of children and teenagers with suspected inflammatory bowel disease (IBD) referred for endoscopy do not have the disease. The investigators designed a clinical decision rule that included a calprotectin stool test to discern which patients require further investigations. The accuracy of this diagnostic strategy is 88.5% with a low risk of missing IBD cases. Although the number of negative endoscopies was reduced after introduction of this strategy, still 22% of the referred children and teenagers underwent an unnecessary invasive test. S100A12 (calgranulin C) is a cytoplasmic protein secreted exclusively by activated neutrophils and this stool marker may be more IBD-specific than calprotectin. OBJECTIVE: To determine whether the specificity of S100A12 is superior to the specificity of calprotectin without sacrificing sensitivity HYPOTHESIS: Inclusion of the calgranulin C stool test will improve the specificity of the screening-strategy.

Inflammatory Bowel Diseases (IBD) are life-long, incurable illnesses that can have a profound effect on the patients quality of life. Disease education is a corner stone of IBD care to enable patients to take up an active role in their disease management. While patient education is enshrined in the IBD standards, actual patient knowledge is often poor.3 Knowledge is not associated with the level of the patient's educational achievement, but member of patient organisations such as Crohn's and Colitis UK (CCUK) have significantly better knowledge than non-members. This may highlight the positive effects of education offered by CCUK, but it is also conceivable that patients with a greater interest in their disease are more like to join organisations like CCUK. Different sources of patient information may therefore influence what level of disease related knowledge a patient achieves. Apart from high quality clinical information provided by professional organisation (British Society of Gastroenterology, European Crohn's and Colitis Organisation), the National Health Service and charities (CORE, CCUK), there is also a host of unregulated information available. The emerging dominance of the internet for information gathering has provided easy access for patients to a host of websites providing information on IBD. A number of these provide alternative (not evidence based) views, which could have a potentially negative impact on patient's knowledge. Furthermore patients often share their stories on internet forums and it is likely that those stories share are more likely to represent the extreme ends of disease rather than those experienced by the majority. This could potentially cause anxiety in patients with IBD. The quality of information found on the internet varies widely and up to 50% of websites have been judged as poor. The vast majority of patients with IBD have access to the internet and more than half use to search for health related information.7 We have previously also demonstrated that patients with anxiety have better disease related knowledge of IBD.

This study will be a prospective, open label, randomized, comparative study. Comparing the efficacy of adalimumab with immunomodulator therapy (i.e. 6-mercaptopurine, 6-MP), in maintaining remission of post-operative CD patients, with a high risk of disease recurrence. Patient assessment for efficacy will be conducted through interval endoscopic surveillance at 24 and 52 weeks. Patients in the adalimumab arm, showing endoscopic remission at 52 weeks of therapy, will be re-randomized to either maintain adalimumab therapy for an additional 52 weeks or conclude therapy. A third endoscopic assessment for these patients will be conducted at 104 weeks. The investigators expect a substantial increase in both endoscopic, as well as clinical remission rate in patients on adalimumab therapy.

A double-blind, multicentre, stratified by centre, randomised, parallel study with two groups of adult patients operated on for Crohn's disease, to determine if oral ingestion of probiotics could prevent the appearance of Crohn's disease recurrent endoscopic ileo-colonic lesions 12 months after surgery. Patients will consume 900 mg/day of active product (N=56) or control product (N=56) during one year.

This study of Humira will be conducted to obtain information on the safety (especially profile of malignant tumors and serious infections) and effectiveness in patients with Crohn's disease who are receiving Humira for a long period of time.

The purpose of this study was intended to evaluate the long-term safety and effectiveness of adalimumab in participants with Crohn's disease (CD) who are treated as recommended in the product label.

Pediatric Crohn's Disease is a life long disease , presenting early in life.As such , it is imperative to be able to evaluate the risk for more severe disease and poorer outcomes when making the decision which therapies to offer our patients. These decisions should be based according to longer-term disease outcomes, such as whether they prevent disease relapse or prolong remission [10-12]. However, for the most part, previous studies were not designed to yield predictive parameters that could allow a clinician to differentiate which patients are at a higher risk for relapse, or more likely to to have serious attacks or complications of the disease or therapy. The ability to predict these risks would impact dramatically the way CD patients are treated, allowing the clinician to tailor therapy, both type and intensity, to each patient's individual risk for relapse and outcomes.In the present first phase of the study , we will attempt to identify factors that predict relapse of the disease, focusing on the use of calprotectin at onset and after clinical remission, and on the use of anti-glycan antibodies, as well as disease severity, site and phenotype.

Prospective, observational, parallel-group, postmarketing safety surveillance registry in participants treated with Remicade or standard therapy for active or fistulizing Crohn's disease (CD). The follow-up period is up to 5 years. The participants in the standard therapy group may switch over to Remicade any time during the follow-up period

Janssen Inc. plans to collect data on about 3000 to 5000 infliximab infusions per year, starting in the third quarter of 2005. It is expected that about 12 sites from the Remicade Infusion Network (R.I.N.) will participate. This registry will be a multicentre, prospective, observational program that will gather and analyze data on subjects being treated with infliximab.

What is known? the impact of AZA, immunomodulatory drug widely used in active CD, on the intestinal wall differs from those of steroids, what is reflected in the significant difference in the postoperative anastomotic leaks rate AZA inhibits intestinal epithelial cell growth by inducing the apoptosis and inhibiting proliferation of intestinal epithelial cells in in vitro studies What is new? The effect of AZA on cellular damage was assessed in humans' study AZA increases cell apoptosis in the intestinal epithelium of active CD patients, much stronger than steroids AZA actively promotes the DNA damage repair in the intestinal epithelium; the steroid effect, even when combined with AZA, is not so pronounced The intensity of proliferative processes, in contrast to steroids, is significantly inhibited in response to AZA The disintegration of the mucosa layer in response to AZA is observed The difference in the mechanisms of action of AZA and steroids on the intestinal mucosa may be directly related to the reported difference in the risk of septic postoperative complications, but this requires further research