Active clinical trials for "Crohn Disease"

Observational, prospective, single-center follow-up study carried out with patients from the area of the Virgen de Macarena University Hospital, diagnosed with chronic kidney disease, who started treatment with ustekinumab.

INTRODUCTION: Vedolizumab is a gut selective anti-integrin agent which binds to the alfa4beta7 integrin, preventing its coupling to the endothelial MadCAM-1. It reduces leucocyte trafficking from the endothelium consequently reducing intestinal tissue inflammation. There is scarce evidence on the use of vedolizumab in CD in Brazil, mostly in patients with no previous biological therapy, where the drug seems to have a more adequate therapeutic potential. Tha primary aim of the study is to analyze clinical remission rates at weeks 12, 26 and 52, and at last follow-up on naive CD patients submitted to vedolizumab therapy. Secondary outcomes will be clinical response rates at weeks 12, 26 and 52, and at last follow-up; endoscopic remission rates in colonoscopies performed; persistence of drug therapy over time; adverse events during treatment with vedolizumab and rates of abdominal surgery during therapy. METHODS: A retrospective, longitudinal, observational study will be performed with patients with CD who used Vedolizumab at any time of their treatment as the first biologic option, after failure of conventional therapy. Following the induction dose of 300 mg at weeks 0, 2 and 6, and maintenance of 300 mg every 8 weeks, patients will be followed up to 52 weeks (1 year) or more (last follow-up captured). Records of the clinical evaluations at week 12, 26 and 52, and last follow-up, will be checked according to the HBI and PGA to define clinical response or clinical remission. Colonoscopies will also be checked to evaluate mucosal healing. Electronic charts will be reviewed also to analyze adverse events and surgery during therapy.

By capturing possible or known risk factors, it will be possible to recognize connections between these risk factors and the disease, thus obtaining valuable insights into the cause of the disease. This in turn facilitates an improved evaluation of the treatment situation as well as influencing future framework conditions for preventive measures and planning treatments. Disease registries are thus crucial for the planning and structuring of health policies. The present registry protocol serves as a basis for the proper implementation of a registry for patients with chronic inflammatory bowel diseases. It describes the study rationale, objectives, design, participant groups, procedures and evaluation methods. Furthermore, it defines the responsibilities of each person involved in maintaining the registry and also forms the basis for decisions regarding evaluation by the Ethics Committee.

The purpose of this study is to validate the use of a low-dose computed tomography (CT) protocol and facilitate reduced radiation doses in patients with inflammatory bowel disease (IBD). This is to be achieved using new computer software (Iterative Reconstruction and Automatic Tube Modulation) which will enable low-dose CT imaging at doses equivalent to that of an abdominal radiograph.

Up to ¾ of patients who have been diagnosed with Crohn's disease (CD) will have to undergo bowel resection during their lifetime despite modern medical therapies. Unfortunately, disease recurrence is common and endoscopic detection of recurring inflammation precedes clinical relapse. Endoscopic investigation is therefore recommended to manage these patients. This multi center, prospective study compares the conventional endoscopic method, ileo-colonoscopy to a new technique, i.e., colonic capsule endoscopy (CCE). CCE enables investigation of the small bowel and the large intestines by using a double-sided video camera with about 10 hours acquisition time. This study aims to evaluate the performance of CCE to detect postoperative recurrence of CD and detection rate of colonic and anastomotic recurrence is compared to ileo-colonoscopy. Proximal (small bowel) lesions are additionally recorded and impact on clinical management of the findings is accounted for. Moreover, safety aspects and influence of the findings on progress of the disease are monitored. All consecutive patients who are operated for CD in any of the participating study centers are eligible. Included are patients with segmental small bowel, ileocecal or segmental colonic resection. In some cases capsule retention has been reported at an average of 2-3% with CD patients at elevated risk. Therefore, patency capsule is performed before application of the video CCE to exclude bowel obstruction. Sample size estimation results in n = 70, requiring each 140 capsule endoscopes and 140 patency capsules for performance of postoperative screening (ca 4-8 weeks postoperatively) and detection of postoperative recurrence (ca 4-8 months postoperatively).

The aim of our study is to suggest possible underlying mechanisms for the observed clinical differences in disease severity and behavior of overweight and obese patients with crohn's disease(BMI > 25 kg/m²)as compare to non-obese crohn's patients with a normal or low weight ( BMI ≤ 25) by measuring metabolic\nutritional variables and cytokine levels.

Crohn's disease (CD) is a relapsing-remitting condition that requires lifelong monitoring. Non-invasive tests such as faecal calprotectin (FC) are more acceptable to patients and cost-effective than invasive tests such as colonoscopy. FC levels can also accurately predict the degree of healing seen within the bowel at colonoscopy. FC testing is labour intensive, and results are often indeterminate. There is interest in a newer test called quantitative Faecal Immunochemical Testing (qFIT) in patients with CD. qFIT measures the amount of blood within the stool and is used in the Scottish Bowel Cancer Screening Programme. qFIT is an easier and more acceptable test for patients and is less labour intensive and cheaper for the lab to process than FC. qFIT is a useful test to 'rule-out' significant colorectal pathology including bowel cancer, high risk polyps and inflammatory bowel disease in patients in the primary care setting. It has also been used to predict the degree of healing seen within the bowel at colonoscopy and to predict the risk of relapse in patients with UC, but not in CD. There are no studies in the UK to date comparing FIT to FC as a monitoring test in patients with well-controlled CD. Unpublished audit data from our group has suggested that low serum zinc has higher predictive accuracy at determining risk of future flare than both FC and CRP; we are unsure if this is due to higher faecal losses in 'grumbling' CD patients. This study could identify a cheaper, more acceptable and easier to interpret test to guide disease activity monitoring, flare risk and treatment decisions in quiescent CD.

The inflammatory bowel diseases (IBDs), ulcerative colitis (UC) and Crohn's disease (CD), are characterized by lifelong relapsing-remitting gastrointestinal inflammation, with symptoms of abdominal pain, diarrhea, and rectal bleeding during active disease. Medical therapy reduces intestinal inflammation and ameliorates symptoms. Clinical remission is defined when symptoms are resolved. In these periods, patients are able to perform daily activities more freely and lead a normal lifestyle. Biochemical remission (normalization of CRP and fecal Calprotectin) and endoscopic remission (no visual signs of inflammation of the mucosa in endoscopy) are the goals of IBD treatment. Unfortunately, 30-40% of patients will relapse during 6 months from achieving remission. Risk factors for disease exacerbation are still unknown, and no guidelines exist as to the prevention of relapse and maintenance of remission in IBD patients. In addition to the above, sleep disturbances and disturbances in the circadian rhythm can be a potential cause of flare-up. Sleep disorders cause changes in immune function, which later affect the course of the disease in IBD. This back affects the sleep pattern, so that a cycle is created, which may perpetuate the inflammation. The interactions between sleep and inflammation are complex. An effective immune system affects sleep, and sleep disorders affect the functioning of the immune system. Furthermore, changes in the biological clock and sleep deprivation have been directly shown to worsen ulcerative colitis in laboratory animals. In people with sleep disorders, high levels of inflammation were found. However, it is difficult to dissect the cause and effect for these associations, given their complex interactions. Therefore we are planning to conduct a prospective study to assess variety of factors that might be associated with the activity of IBD.

Patients with inflammatory bowel disease (IBD) are increasingly becoming interested in nonpharmacologic approaches to their disease. One of the most frequently asked questions of IBD patients is what they should eat. The role of diet has become very important in the prevention and treatment of IBD. Although there is a general lack of rigorous scientific evidence that demonstrates which diet is best for certain patients, several diets have become popular. Aim of the Work To assess IBD patients' knowledge about the role of nutrition in the management of their Inflammatory Bowel Disease and the dietary beliefs, behaviors, and daily dietary practices in adult IBD patients that they make to avoid exacerbation of disease symptoms or to gain more control of bowel symptoms, keeping in mind our traditional and oriental food and food habits in Egypt. Also to evaluate the role of one of the most common dietary regimens; the Paleolithic diet in active mild or moderate inflammatory bowel disease.

Perianal Crohn's disease (pCD) is the commonest form of fistulising Crohn's disease, with up to 38% of patients affected and with 30% of them experiencing recurring disease symptoms. Presence of fistula can lead to major morbidity due to cutaneous perianal abscess formation or drainage. To date, it is very difficult to quantify inflammation in patients with pCD due to the absence of reliable disease activity measurements. In addition to this, optimising therapies for pCD is quite challenging and may have a major impact on quality of life. Magnetic resonance imaging of pelvic is a standard examination for the anatomical evaluation of pCD which is significant in terms of surgical therapy and progress. The overall hypothesis is that newer MRI techniques such as magnetization transfer (MT), diffusion weighted image ( DWI) and dynamic contract enhancement (DCE) are better suited to measuring the inflammatory vs fibrotic burden in pCD. The aim of this project is to measure disease activity within pCD and luminal CD using MRI sequences before and after biological therapy