View clinical trials related to Colitis.
Filter by:The aim of the study is to evaluate the soluble biomarker syndecan-1 (sSdc1) taken from venous blood of patients with infectious intestinal diseases such as Clostridium difficile-associated colitis, bacterial colitis, Norovirus enteritis and Crohn´s disease or ulcerative colitis. The level of sSdc1 will be compared with disease activity in patients with active inflammation and with disease in remission. Secondary objectives were the assessment of correlation of the above-mentioned factors with the CRP value. Subjects will be volunteers. Blood will be taken as part of the routine clinical work-up after the written agreement blood and sSdc1-level will be assessed using a human-specific sSdc1 ELISA assay. In addition, the subjects are asked to answer a short questionnaire. The study is designed as a prospective, comparative cohort study.
The primary aims of this phase I/II, randomized, placebo controlled study are the assessment of safety and tolerability of universal donor FMT compared to placebo in pediatric and young adult subjects (ages 5 years through 30 years) with active ulcerative colitis (UC) or active Crohn's colitis (CD) who have failed, are intolerant to, or have refused traditional first-line maintenance therapy. Secondary objectives include the identification biomarkers in both donor and recipient that may confer a clinical response and to establish whether or not ongoing FMT maintenance therapy is required for maintenance of clinical benefit in pediatric UC or pediatric CD.
The primary aim of this phase I/II, randomized, placebo controlled study is the assessment of safety and tolerability of universal donor FMT compared to placebo in pediatric and young adult subjects (ages 5 years through 30 years) with active Crohn's colitis (CD) who have failed, are intolerant to, or have refused traditional first-line maintenance therapy. Secondary objectives include the identification biomarkers in both donor and recipient that may confer a clinical response and to establish whether or not ongoing FMT maintenance therapy is required for maintenance of clinical benefit in pediatric CD.
An observational, prospective cohort study to evaluate the safety and efficacy of Remsima™ in patients with Crohn's disease (CD) or Ulcerative Colitis (UC)
HealthPROMISE is a mobile application (app) for patients that allows regular tracking of symptoms by patients and communicates them to physicians. The purpose of this randomized controlled trial is to determine the impact of the HealthPROMISE application on improving patient outcomes. The trial will look at how much patients use the application, whether physicians change treatment in response to new information from patients, and how the patients quality of life change over the span of the study. The investigators hypothesize that HealthPROMISE will enhance physician-patient communication and improve clinical outcomes.
Inflammatory bowel disease (IBD) refers to two chronic diseases (Crohn's disease and ulcerative colitis) that affect the intestines. The number of new cases of IBD in people younger than 16 years old has been increasing in the United Kingdom (UK), and is currently estimated to be 700 new cases every year. There is no cure for IBD and patients experience episodes of flareups in between periods of wellbeing. Traditionally, children with IBD are asked to attend regular hospital appointments. This means that, even if they are well, they have to get to the hospital and this can involve travelling long distances. Telephone consultations have been shown to be beneficial in some areas of medicine but this approach has not been well studied in children. The aims of this study are to determine whether telephone consultations would improve quality of life, patient satisfaction, proportion of consultations attended and whether they would be safe and reduce costs for patients and the National Health Service (NHS). Investigators plan a randomised controlled trial involving 92 participants recruited from amongst the 250 children and adolescents aged between 8 and 16 years who attend the regional paediatric IBD centre in Manchester. Half will be assigned to telephone consultations, and half to face to face consultations. The study would have the approval of the local ethics committee and participants would have provided written consent. Investigators will compare outcomes in the two groups over 2 years. If telephone consultations prove to be effective, the NHS could offer children with IBD the choice of either telephone consultation or face to face consultation for their outpatient followup. Those who are doing well would not have to make unnecessary journeys to the hospital. This would free up clinic spaces and allow patients who are unwell, and new patients to be seen more quickly, thus reducing waiting
The purpose of this study is to evaluate serum soluble human ST2 protein, the receptor for Interleukin-33 (IL-33) and a member of the proinflammatory Interleukin-1 (IL-1) receptor superfamily, as a surrogate biological marker predictive of disease outcome and therapeutic response to golimumab treatment in participants with moderate to severe UC who have failed on prior conventional therapies. The primary endpoints of this study are to correlate serum soluble ST2 levels with endoscopic activity (endoscopic subscore of the Mayo score) and histological activity (Geboes index) of disease.
The investigators will test the hypothesis that that greater efficacy of anti-tumor necrosis factor (antiTNF) therapy results in reduced need for bowel resection surgery, fewer serious infections, and reduced short term mortality risks, and therefore has a more favorable benefit to harm profile than corticosteroids for inflammatory bowel disease.
The CIDsCaNN Network is being established with the major goals of identifying why IBD develops so commonly in children and adolescents living in Canada, and of determining the best treatment strategies for different types of IBD. Focusing on a prospective, inception cohort of Canadian children of widely varied racial origins provides a unique opportunity to explore environmental risk factors early in life and close in time to disease onset, their influence on the host microbiome, and in the context of genetic susceptibility. In keeping with current treatment targets, assessed outcomes will include not only symptom resolution and growth, but also intestinal healing. We aim to identify best practice and to institute processes for continual improvement in care nationally.
This is a Phase I, open-label, single-site trial to evaluate the drug release, using scintigraphic images and mesalazine plasma levels (PK) in healthy subjects and patients with mildly active UC. Overall, nine [9] subjects per prototype coating (a total of 18) will be evaluated. Four [4] healthy subjects and five [5] patients will be administered one [1] radio-labelled tablet of either formulation D or formulation E, respectively. Amendment: Overall, nine [9] subjects/patients will be evaluated. Four [4] healthy subjects and five [5] patients will be administered one [1] radio-labelled tablet of this new third improved formulation H. In order to keep the number of patients low, recruitment of patients will be stopped when obtaining at least 3 patients with evaluable scintigraphic images. Healthy volunteers will then be recruited to achieve a full set of participants (n=9 per Arm).