Active clinical trials for "Inflammatory Bowel Diseases"

The measurement of serum concentrations of infliximab (IFX)has now become a routine part of optimal use of that drug. Trough values are used in two situations: (a) reactively where there is loss of response to infliximab - therapeutic concentrations are indicate likely non-response to the drug, whereas low levels are associated with the chance of regaining response by increasing dosage; or (b) proactively, where dose optimisation in the maintenance phase is performed to ensure ongoing efficacy and/or cost-effective use (where high levels lead to reduction in dosage without loss of efficacy). With the introduction of biosimilar infliximab into clinical practice, it is important to demonstrate that the biosimilar behaves similarly in the assay used as does originator infliximab to which the assays were developed. While unlikely to be different due to identical protein core, such confirmation is needed before such assays can be used in clinical practice with confidence. AIMS To compare the concentrations of biosimilar IFX (MSD-IFX) with that of originator IFX (orig-IFX) when added to serum form healthy subjects and those with IBD when measured by commonly-used commercial assays. To compare the effect of freeze-thawing and storage at 4 oC on concentrations of MSD-IFX.

The PREdiCCt Study: This is a major study that is now being launched. This is the first study of its kind and is specifically directed toward understanding how environmental factors and the gut microorganisms influence IBD flare and recovery. For the PREdiCCt study, the investigators hope to recruit 3100 people in remission from Crohn's disease or ulcerative colitis (illness under control) from 28 inflammatory bowel disease clinics across the UK. The investigators hope to conduct the study in the following stages;- Patients with Crohn's disease, ulcerative colitis or inflammatory bowel disease unclassified (IBDU) in clinical remission (under control) will be approached in gastroenterology clinics across the country and invited to take part in the PREdiCCt study. Alternatively they will express their interest in the study after seeing PREdiCCt promotional leaflets/posters/videos/social media. Participants will attend a clinic visit for routine tests and also to complete several questionnaires with a research nurse. At home over the next week participants will complete detailed questionnaires assessing their environment and diet. Participants will also collect a stool and saliva sample and send this to our laboratories (the investigators have developed easy ways of doing this reliably by post). The stool sample is to analyse the microorganisms in the participant's gut and the saliva is used to analyse their DNA. In addition to this the participants are asked to complete a 4-day weighed food diary. The food diary is sent to the University of Aberdeen for analysis. Investigators will then follow patients' progress over 24 months. They will be asked to complete a short questionnaire every month with a longer questionnaire after 12 months and culminating in a final questionnaire 24 months after their initial clinic visit. If a participant experiences a flare, investigators will collect an additional stool sample; but most importantly investigators will look to see how the environmental and microorganism factors recorded at the beginning differ for those that flare up versus those that don't. What investigators hope to achieve;- Finding out the environmental and dietary factors for patients to avoid because they trigger flare. Finding out behaviours for patients to adopt because they bring about remission. Finding out what the microorganisms that predict flare look like. Gaining information which helps future studies aimed at finding better diets for IBD sufferers. Developing ways of gathering information online from IBD patients about their well-being that doctors can routinely use. The investigators have assembled expert doctors, epidemiologists, microbiologists, nutrition scientists, and bioinformaticians. These experts will use the systems the investigators have put in place to make sure PREdiCCt succeeds. It will yield a lot of new information to help sufferers right away; but the information will also help to kick start many important future studies that will bring us ever closer to a cure for Crohn's disease and ulcerative colitis.

Nutrient deficiencies occur frequently in IBD patients. The absorption rate of nutrients in IBD is often limited by chronic inflammation, but is also commonly reduced by missing intestinal segments due to previous operations. Patients are predominantly affected by malnutrition, which is often resembled by weight loss, specific micronutrient deficits such as iron deficiency, vitamin B12 deficiency, folic acid deficiency, vitamin D deficiency and zinc depletion. The etiology of nutritional problems is multifactorial and not exclusively limited to active phases of the disease. Causes of malnutrition can be inadequate food intake, maldigestion, malabsorption or increased nutritional requirement. Malnutrition itself is associated with a delayed recovery of impaired wound healing, reduced quality of life and longer hospital stays. Therefore, observation and modification of the nutritional status should be an integral part of therapy in IBD patients. The primary objective of our study is to investigate the influence of the disease on the resting energy expenditure and nutritional status during acute inflammation and clinical remission of the disease. Secondary objectives are to assess possible nutritional deficiencies. On the other hand it is well known that patients with IBD are at increased risk for coronary heart disease. Therefore, another secondary focus of our observational study is whether the composition of the HDL proteins is changed towards pro-atherogenic HDL-proteins and whether possible changes occur in patients in clinical remission or with active disease.

The advancement in life-saving technologies and clinical expertise in the care of extremely premature infants, have resulted in the development of large neonatal intensive care units (NICU). It has been suggested that reconstruction of megaunits of neonatal intensive care to smaller care units with specific patient population and clinical team providers will be essential to maintain optimal teamwork, quality of care and patient outcome. Despite the growing knowledge around the need for reconstruction of large NICUs to smaller units of care, there is no evidence regarding the safety and efficacy of microsystem model of care on the key aspects of health care. At the McMaster Children's Hospital (MCH), we planned a change from standard model of care to the microsystem model of care and therefore we aimed to prospectively assess the effect of this organizational change on the variable aspects of health care. A working group met weekly to formulate the implementation planning, to review the adaptation and adjustment process and to ascertain the quality of implementation following the initiation of the microsystem model. The study was retrospectively registered.

The investigators are going to study von Willebrand antigen and activity levels in patients with inflammatory bowel disease. The study will be on 46 patients who were diagnosed with inflammatory bowel disease mainly ulcerative colitis and Crohn's disease divided into two arms; group A will include 23 cases with active IBD(cases)status and group B will include 23 cases with inactive IBD status(control) to compare the vWF antigen and activity ( expected to be higher in active disease group. The investigators will follow all of the patients for any arterial or venous thrombosis to evaluate IBD as a risk factor of thrombosis, on the other hand, they are looking to detect cases of acquired von Willebrand syndrome in some cases with bleeding that not explained by the inflammatory bowel disease status. The aim of the work: Assessment of VWF antigen in patients with inflammatory bowel disease and correlate it to disease activity. Evaluation of VWF antigen as a risk factor for thrombosis in inflammatory bowel disease patients. Detection of acquired von Willebrand disease in inflammatory bowel disease.

EDUMICILOR is a monocentric prospective pilot study for patients with inflammatory bowel disease (IBD). During the study, patients will participate in an online therapeutic education program. They will first have an appointment with a nurse to establish a personalized educational diagnosis. Then they will participate in the online therapeutic education program for about 6 months (depends on the educational needs, expectations and patient's availabilities). The main objective of this study is to assess the feasibility of an online therapeutic education program for IBD patients.

Trial for IBD patients non-responsive to biological drugs, using medical app reminding patients to take their physician-prescribed medications

Heart disease and failure are the major causes of mortality and morbidity worldwide, despite significant advances in medical technologies in the diagnosis and treatment of the disease. Cardiovascular disease may arise for various reasons including the steadily increasing incidence of obesity, type 2 diabetes, genetic, environmental, dietary and lifestyle factors. Besides all these, there is much evidence suggetsing that inflammation is an important player in the pathogenesis of heart disease, as well as atherogenesis and atherosclerosis.

The purpose of this study is to evaluate the efficacy of confocal laser endomicroscopy in assessment of colonic permeability against conventional sugar absorption test.

Inflammatory bowel disease (IBD) is a chronic idiopathic inflammatory condition of the intestine, which results in diarrhea, rectal bleeding, urgency, weight loss and abdominal pain. The natural course of IBD is characterized by activity outbreaks and periods of remission. In most cases, relapses in Crohn's disease (CD) and in ulcerative colitis (UC) are unpredictable and despite effective medical treatment, a degree of subclinical inflammation may persist in the bowel wall, contributing to a significant risk of relapse. In IBD, altered fecal microbiota signatures have been consistently reported which included a reduction in biodiversity with lower proportions of Firmicutes and increases in Proteobacteria and Bacteroidetes phylum members. It is however unclear whether changes in microbial profile including diversity and composition can predict disease relapse in IBD. We hypothesize that fecal microbial signatures in conjunction with fecal calprotectin may play a role in predicting relapse in IBD patients.