View clinical trials related to Colitis, Ulcerative.
Filter by:Inflammatory bowel diseases (IBD) represent a group of immune-mediated disorders, in which currently unidentified trigger factors drive the manifestation of chronic relapsing- remitting destructive inflammatory episodes in the gut. IBD comprise two main disease entities, ulcerati\ie colitis (UC) and Crohn s disease (CD). The diseases differ in anatomical distribution, with continuous, uniform inflammation restricted to the colon in UC, and multifocal inflammation extended throughout the entire gastrointestinal tract from mouth to anus in CD. Clinical symptoms of IBD may include bloody stools, abdominal pain, fatigue, diarrhoea, fever and weight loss. Extra-intestinal symptoms occurring in up to 40% of patients, e.g. anaemia, skin lesions (e.g. erythema nodosum, pyoderma), arthritis and uveitis, and other complications directly related to the disease organ, such as fistula in CD are considered to reflect an overwhelming systemic inflammatory state. Disease onset typically manifests at age 15-35 years, men and women are almost equally affected. In addition, paediatric forms of IBD that often represent complex, se\/ere monogenic forms of the disease, are seen. The incidence rates of IBD in Europe are about 6.3 (CD) and 11.8 (UC) per 100.000 persons. With growing incidence rates and overall reduced mortality the lifetime prevalence of IBD is expected to rise. The estimated lifetime prevalence of 0.3%-0.5% of the European population corresponds to estimates of 1.5-2 million patients with IBD. Appropriate selection of therapies and their timing of introduction (decision support) in the course of IBD will be essential to reach a higher degree of disease control (across patients and within individual patients) than it is achie\led today. In many instances, comparati\ie data is missing and combinations or sequential therapies are not developed. In summary, despite some treatment successes, major challenges remain. The investigators have decided to include patients with inflammatory bowel disease (IBD) in which targeted therapies are administered as part of standard helathcare and which aims at identifiyng solid biomarker signatures as well as molecular pathways and mechanisms linked to response and non-response to therapy. Choice od medications (which are all approved for first line use) is by treating physicians. All follow-up procedures are according to standards of care.
The protocol of this Phase 2 clinical trial consists of a double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the efficacy and safety of dupilumab in participants with moderately to severely active Ulcerative Colitis (UC) with an eosinophilic phenotype. Screening period: 2 to up to 4 weeks Treatment period: 52-week investigational medicinal product (IMP) intervention (dupilumab or matching placebo) from Week 0 to Week 52 Open-label arm (optional): administration of open-label dupilumab therapy for study participants who qualify. Follow-up period: 12 weeks The maximum duration of study per participant is up to 68 weeks.
Ulcerative colitis (UC) is a chronic remitting and relapsing inflammatory bowel disease. The pathogenesis is multifactorial, involving genetic predisposition, epithelial barrier defects, dysregulated immune responses, and environmental factors. It is diagnosed through colonoscopy and histological evidence of mucosal inflammation involving predominantly the rectum and potentially extending continuously up to the proximal segments of the colon. The patients affected present with severe abdominal pain, bloody diarrhea together with extraintestinal manifestations such as peripheral arthritis, pyoderma gangrenosum, erythema nodosum, ankylosing spondylitis and many others. The last 20 years have been profitable from the therapeutical point of view thanks to the advent of biological drugs which are derived from a living organism or its products including antibodies, interleukins and other molecules capable to target specific cellular pathways and to modulate different mechanisms such as blocking the actions of cytokines or white cells movement in the gut. More recently new promising alternatives seems to be the so-called small molecule drugs which are chemically derived low molecular weight compounds capable to enter the cell to regulate its functions and more generally biological processes like inflammation. In the last years, the therapeutic offer for ulcerative colitis patients has been enriched with the advent of biologics with different mechanism of action and very recently with the availability of the small molecules. Currently the available therapeutic options for ulcerative colitis include topic and systemic mesalazine, topic and systemic glucocorticoids, immunosuppressants (thiopurines), biological drugs (anti-tumor necrosis factor α (TNFα), inhibitor of α4β7 integrin, anti-IL12-23) and small molecules (JAK inhibitors). However, if on the one hand the therapeutical enrichment has clearly improved the disease rate control, still there is the need to perform sequencing study to stratify the available options to provide the best and most appropriate patient-oriented management.
Constitution of a biobank of tissues, whole blood and plasma samples and stools to identify markers associated with treatment response, postoperative morbidity including neuro-cognitive and mood complications and prognosis of Inflammatory Bowel disease or colorectal cancer.
The primary goal of the study is to develop an early (within 4 weeks) combined microbiota/metabolic signature predicting clinical response upon anti-inflammatory treatment in UC patients.
This study aims to investigate possible efficacy and safety of Roflumilast in adult patients with ulcerative colitis disease .
Immune-mediated diseases are extremely diverse - patients with the same diagnosis may see the disease progress in very different ways, and respond differently to treatments. This is because the course of the disease is influenced by multiple factors, including the patient's genes, immune system, environment, and the microbes living in their gut. Furthermore, all of these factors interact with and impact on one another. As a result, it is very hard to predict how the disease will develop in a specific patient, and which treatments will be effective. Hence, mechanistic understanding of this heterogeneity and biomarkers predictive for disease control and therapy response over time are important prerequisites of a future precision medicine in IMIDs. ImmUniverse has been formed as a European transdisciplinary consortium to tackle these unmet needs and to understand the role of the crosstalk between tissue microenvironment and immune cells in disease progression and response to therapy of ulcerative colitis (UC) and atopic dermatitis (AD). The consortium will combine analysis of tissue-derived signatures with "circulating signatures" detectable in liquid biopsies, employing state-of-the-art profiling technologies to provide new validated diagnostics in IMID that are expected to improve patient management, lead to increased patient well-being and will significantly reduce the socioeconomic burden of these diseases. This study, being Immuniverse work package 5 (WP5), will verify the disease pathway -and mechanism signatures identified in the multi omic discovery WP2 in immune cells in affected tissue and peripheral blood. WP5 aims to further substantiate our understanding of the immune-mediated intestinal disease ulcerative colitis (UC). It will use liquid biopsies (peripheral blood) and affected UC gut inflamed and non-inflamed biopsies to generate transcriptome, proteome, DNA-methylome and miRNA signatures of immune cell subsets and analyse the association between immune cells circulating in peripheral blood and the microenvironment of affected colonic tissue. Also this WP aims to develop a protocol to analyse and sort living immune cells from cryopreserved tissue. Ultimately, the project's findings should contribute to a better, more precise diagnosis for patients; and better information on how severe the disease is likely to be for each individual patient and how it will progress over time. Finally, the project will make it easier for doctors and patients to monitor how well a treatment is working in the future.
This study included two topics: one was to test the efficacy and safety of fecal microbiota transplants plus partial enteral nutrition (PEN) in refractory pediatric UC where conventional therapy has failed, and the other was to explore the efficacy and safety of FMT plus PEN as first-line therapy for pediatric active UC
Rates of inflammatory bowel disease (IBD) are increasing rapidly in children and young people, and targets for management are becoming more demanding, with better control of disease to prevent complications, cancers and surgeries. This project "Non-Invasive Monitoring Through Bowel Ultrasound in Paediatric Inflammatory Bowel Disease" or NIMBUS study will aim to explore the possibility of using ultrasound to examine inflammation in this group. Monitoring inflammation in this population currently is done with regular endoscopy (camera tests) and/ or MRI enterography scans which are invasive, can be uncomfortable, expensive and may have long waiting lists. These studies also require bowel prep, in the form of laxative medicines which can be distressing and cause time off from school. Direct visualisation through ultrasound could allow better monitoring of disease, and is quick, accurate, non-invasive and relatively low-cost. This could also allow for more appropriate medication use and a decrease in over/under use of medicines. This study will aim to recruit 50 children and young people with inflammatory bowel disease. Each child will have an ultrasound scan after enrolment and the investigators will use the information from these scans, as well as routine blood tests (already taken in normal care) and follow up medical information to explore the use of ultrasound in this group. The investigating team will aim to contribute to the global discussion around this topic and if results are positive will aim to improve monitoring for this population managed at the Noah's Ark Children's Hospital for Wales.
The primary objective of this study is to evaluate the long-term safety and tolerability of efavaleukin alfa in participants with moderate to severe ulcerative colitis (UC).