View clinical trials related to Ulcerative Colitis.
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The purpose of this retrospective observational cohort study is to assess pregnancy and infant outcomes in three groups: the first is women with ulcerative colitis (UC) who were exposed to ozanimod during pregnancy; the second is women with UC exposed to conventional therapy during pregnancy; the third is women with UC exposed to advanced therapy during pregnancy. This study will use data from a large US healthcare claims database.
The intestinal epithelial barrier is one of the most important security checkpoints of our body that constrains harmful factors from invading mucosal surfaces and facilitates the absorption of nutrients and water. Its correct functioning is essential for maintaining gut tissue homeostasis and proper immunity. However, such an equilibrium may be interrupted, resulting in an uncontrolled entrance of pathogenic stimuli that in turn activate a persistent gut immune response, with detrimental consequences for both local and systemic immunity. Alterations in the composition and functionality of the gut microbiome seem to be a central factor in affecting gut barrier integrity thus influencing intestinal permeability. The microbiome composition is impacted by dietary habits and environmental pollution and conditions, hygiene, genetic asset, and physical activity, which could interact in concert leading to dysbiosis, thereby influencing the immune response through the production of several metabolites. Chronic inflammatory diseases, including ulcerative colitis (UC) and type 1 diabetes (T1D), share microbiota dysbiosis, among pathologic characteristics, that may arise, be provoked, or be exacerbated because of barrier leakage. Therefore, these two chronic diseases may be considered prototype pathologies where the intrinsic connection between intestinal dysbiosis and the barrier leakage impact each other during the pathogenesis.
Crohn's Disease (CD) and Ulcerative Colitis (UC) are chronic inflammatory bowel diseases (IBD). Adalimumab is a human monoclonal antibody against TNF-alpha, a pro-inflammatory cytokine that mediates the inflammatory response in IBD upon binding to the TNF receptors. Primary non-response to adalimumab is high in both CD and UC. Currently, there are no predictors of response to adalimumab and the actual mechanism of action has not yet been elucidated. To gain better understanding of the drug targeting of adalimumab in IBD, the University Medical Center Groningen (UMCG) developed fluorescently labeled adalimumab (adalimumab-680LT). This study aims to assess the safety and the optimal dose of adalimumab-680LT to visualize and potentially quantify the local drug concentration and predict treatment response in IBD patients using in vivo and ex vivo fluorescence molecular imaging (FMI).
The goal of this clinical trial is to determine at how well a new medical food works in managing inflammation associated with ulcerative colitis in children. The main question it aims to answer is: 1) How well does the new medical food lower an inflammatory biomarker known as fecal calprotectin (fCal) in ulcerative colitis as compared to the historical active therapy levels of fCal? Participants will take a specified dose of the medical food in water each day for 12 weeks. The level of fCal will be measured through a stool sample at baseline, one during the 12 weeks, at the end of 12 weeks, and once more at 16 weeks. The levels of fCal will be compared across the 16 weeks and compared with levels before the new medical food was taken.
An aspect of IBD care that is often overlooked is mental health treatment. Common mental health problems, such as anxiety and depression are very common in IBD, with a meta-analysis estimating prevalence as high as 25.2% for depression and 32.1% for anxiety. The prevalence of anxiety and depression increases when individuals with active disease are considered, with rates as high as 57.6% for anxiety and 38.9% for depression. Comorbid depression and anxiety in IBD is associated with greater symptom severity, even when statistically controlling for disease activity; more frequent and expensive emergency department visits and inpatient stays, higher costs relating to IBD-related surgery, medication and personal expenditure; noncompliance with medical treatment and finally, increased likelihood of experiencing flares. However, very few studies attempt to unpick the precise mechanism of these bidirectional relationships. Indeed, depression and anxiety may have direct effects on physical health through inflammatory or psychoneuroimmunological pathways. Very few studies investigate the longitudinal brain-gut relationship with regards to objective measures of inflammation. Additionally, the indirect effects of mental health are often overlooked. Depression and anxiety are routinely associated with health behaviours, such as diet, physical activity, sleep, and tobacco/alcohol use.These health behaviours are important factors, given their impact on physical health outcomes. Therefore, a thorough investigation is required to ascertain the precise mechanisms that underpin the bidirectional relationship between depression/anxiety and inflammation/physical health, as this will enable practitioners and researchers to establish non-invasive, behavioural treatment targets for this patient group. AIM The broad aim of this project is to explore whether anxiety/depression has a direct or indirect (via health behaviours) on i) inflammation levels ii) clinical activity and iii) healthcare usage at follow-up, in a population of IBD patients. A secondary aim of the project will be to explore whether changes in disease activity, as measured by self-report measures and faecal calprotectin, explains changes in anxiety and depression symptoms at follow up.
The goal of this clinical trial is to learn about the treatment with subcutaneous infliximab in patients with inflammatory bowel disease (IBD) that were previously treated with an optimized dose of intravenous infliximab. The main question it aims to answer is: - Is switching to a weekly dose of subcutaneous infliximab (120 mg) associated with a better outcome compared to the standard fortnightly administration of 120 mg subcutaneous infliximab in patients who received an optimized intravenous dosing schedule? Participants will switch from intravenous infliximab to subcutaneous infliximab and will be randomized to the intervention arm (Subcutaneous infliximab weekly) or the interventional comparison arm (subcutaneous infliximab bi-weekly). Participants will follow daily clinical practice in the monitoring for clinical and biological remission. The participants that are willing to switch to subcutaneous infliximab will be compared to a group of participants not willing to switch. These participants will continue to be treated with their optimized intravenous dose of infliximab.
ALTB-268-201 is a Phase 2a, multicenter, single arm, multiple-dose, open-label study evaluating the efficacy and safety of ALTB-268 in subjects with moderately to severely active UC. The study consists of a Screening Phase, an Induction Phase, and a Maintenance Phase. Eligible subjects will be enrolled to receive a SC loading dose of ALTB-268 followed by weekly doses of ALTB-268 for 12 weeks. Primary efficacy endpoint will be evaluated at week 12. Week 12 dosing will occur during the 40 wks Maintenance Phase. During 40 weeklong maintenance phase SC doses of ALTB-268 will be administered every other week. At week 52, all subjects will have an endoscopy performed and efficacy and safety evaluation will take place.
In this clinical trial, the intestinal wall of pediatric patients with Crohns disease and Ulcerative Colitis will be assessed with multispectral optoacoustic tomography (MSOT) to characterize the optoacoustic signal of the intestinal wall and to monitor disease activity. The goal of this clinical trial is to compare the optoacoustic signal in the intestinal wall of children with inflammatory bowel diseases. The main questions it aims to answer are: - How does the optoacoustic signal in children with inflammatory bowel diseases change over time? - How does the optoacoustic signal in children with inflammatory bowel diseases change when they receive therapy? Participants will be examined with multispectral optoacoustic tomography.
The main aim of this study is to learn how the body of a child or teenager with moderately to severely active ulcerative colitis (UC) or Crohn's disease (CD) processes vedolizumab (pharmacokinetics) given just under the skin subcutaneously (SC). The participants will be treated with vedolizumab for up to 34 weeks. During the study, participants will visit their study clinic several times.