Active clinical trials for "Intestinal Diseases"

Since their appearance more than a decade ago, anti-tumor necrosis factor (TNF) inhibitors have demonstrated beneficial activity in the treatment of inflammatory bowel diseases (IBD). However, more than one-third of patients present primary resistance, and one more third become resistant over time. One of the main factors associated with loss of response is the immunogenicity of anti-TNF biologics leading to the production of antibodies targetting the TNF inhibitor, namely anti-drug antibodies (ADAbs), that accelerate drug elimination from the serum and decrease its therapeutic activity. In this study the investigators propose a medico-economic evaluation of the measurement of anti-TNF agents and anti-drug antibodies serum concentrations in the management of patients with inflammatory bowel disease treated with anti-TNFalpha inhibitors. 280 patients with Crohn's disease (CD) or ulcerative colitis (UC) will be included and randomized in 2 groups with or without drug and ADAbs monitoring. In the monitored group, in case of loss of response, the clinician will use biological informations to adapt the treatment following a simple treatment algorithm. In the unmonitored group, drug and ADAbs measurements will not be transmitted to the clinician. Clinical and economical benefits of the biological monitoring will be evaluated after a follow-up period of two years.

Steroid is commonly used to treat autoimmune disorders such as rheumatoid arthritis, lupus, and inflammatory bowel disease (Crohn's Disease and Ulcerative Colitis). However, its use is associated with numerous systemic side-effects, including diabetes, osteoporosis, and potentially significant mood changes. The investigators wish to determine how common patients with inflammatory bowel disease experience mood changes when they take steroid for their disease.

Inflammatory bowel diseases (IBD) is an invalidating disease mainly diagnosed in young people. The disease is characterized by a heterogenic phenotype and the disease course by flares and remissions. As in most chronic diseases the economic burden of IBD is important due to direct health care costs and disability. Health care reorganization for IBD patients in the Netherlands is necessary for several reasons. First chronic (sub)clinical mucosal inflammation results in irreversible bowel damage and complications and none of the presently available drugs is effective for all patients and many drugs have possible severe side effects. To prevent complications of the disease and side effects IBD should be monitored carefully. In the Netherlands however there is a shortage of gastroenterologists where the incidence of IBD is rising. Secondly evidence exists that direct involvement of health care workers, patient empowerment and integrated care can improve the outcome of chronic diseases. Thirdly many clinically relevant aspects (e.g. malnutrition) of this complex disease are not systematically followed in routine care. Finally the government demands registration of efficacy endpoints for expensive drugs in the near future. Therefore the investigators developed a web-based Telemedicine tool for IBD patients in collaboration with the Dutch IBD patient's organization (CCUVN). "myIBcoach" contains E-learning modules, monitors disease activity, disability, quality of life, adherence, infections, smoking status, side effects, stress and malnutrition on fixed time points with validated questionnaires, allows the patient to communicate with health care workers and gives feedback to the back office and the patient. A feasibility study in 30 IBD patients in 3 centres showed a high satisfaction and compliance of IBD-patients and health care workers with this telemedicine tool. The aim of this study is to compare standard care for IBD patients in 3 hospitals with a care via the telemedicine tool myIBDcoach.

The objective of the study is to evaluate the long-term safety and tolerability of treatment with balsalazide disodium tablets in subjects who are in remission from ulcerative colitis or who have mildly to moderately active UC.

The purpose of this study is to determine whether thiopurine S-methyltransferase (TPMT) genotyping prior to thiopurine use is cost-effective in patients with inflammatory bowel disease (IBD) in need of immune suppression. The study is designed to test the hypothesis that optimization of initial thiopurine dose based on pre-treatment TPMT genotyping will maximize treatment efficacy and minimize adverse drug reactions (ADRs) resulting in reduced costs.

There is evidence for the use of a diet low in short chain fermentable carbohydrates (low FODMAP diet) in the management of functional gut symptoms, such as abdominal pain and bloating. However, the provision of advice on the low FODMAP diet can be challenging due to limited resources and the need for a dietitian with expertise in the low FODMAP diet. The aim of this study is to assess the feasibility in terms of recruitment and retention in planning a future trial. The purpose of the future trial will be to investigate the clinical and cost effectiveness, as well as the acceptability of different education methods of the low FODMAP diet for the treatment of IBS. To date, there are no studies on the implementation of the low FOMDAP diet using a mobile app or leaflets in the education of the low FODMAP diet. Therefore, a feasibility study design was chosen in order to obtain key data on recruitment and retention rates at each study group.

The purpose of this study is to evaluate the efficacy and safety of ustekinumab as intravenous (IV: into the vein) infusion in induction study in participants with moderately to severely active Ulcerative Colitis (UC) and as subcutaneous (SC) administration in maintenance study in participants with moderately to severely active Ulcerative Colitis (UC) who have demonstrated a clinical response to Induction treatment with IV ustekinumab.

Over 18,000 Irish people are affected by the inflammatory bowel diseases (IBD), Crohn's disease and ulcerative colitis. These illnesses often arise at a young age and can be associated with significant physical disability. In addition, there is considerable psychosocial disability associated with IBD. Previous studies have suggested that simple psychological interventions may be valuable in improving quality of life and may even improve disease activity. However, there has been no comprehensive trial to determine the precise effect of psychological interventions on quality of life (QOL), stress or disease activity. Our aim is to conduct a randomised controlled trial of a simple psychological intervention to determine it's effect on QOL and stress

The Transition Navigator Trial (TNT) is a pragmatic randomized controlled trial evaluating the effectiveness of usual care plus a patient navigator service versus usual care plus newsletters and other educational materials, to improve transition outcomes among adolescents aged 16-21 who have chronic health conditions requiring transfer to adult specialty care. The study will provide urgently needed data to guide health care providers and policy makers regarding the provision of coordinated transition care. These results have the potential to: Change care delivery Improve health outcomes Improve the experiences of young adult transition to adult care

The aim of this study plan is to implement a tablet quiz in the German-speaking area, in order to test the specific knowledge about chronic inflammatory intestinal diseases (CED) concerning pediatric patients in the context of an age-appropriated and interesting digital playing environment, and to process knowledge gaps at the subsequent doctor's contact. The quiz should be combined with a game and can be performed by the patients, while they wait in the ambulance for their doctor's appointment. The investigator's goals are to grasp playfully gaps in the CED knowledge regarding the patients and to use these in the following consulting hour for clarification and advice in line with a better understanding of the disease. With this, the specific knowledge, the understanding of the disease, the therapeutic adherence, and the self-efficacy should improve the self-responsible handling of the disease. In particular, the willingness of the group of older teenagers to transit into the adult medicine can be collected and processed. The investigators want to check the efficacy in a randomized, controlled study with two groups of 15 pediatric CED patients. The hypothesis is that the additional play of the tablet-CED-quiz and the individualized advice have a positive impact on the CED knowledge, the disease activity, the CED-related life quality and the willingness of teenagers for transition.