View clinical trials related to Inflammatory Bowel Diseases.
Filter by:Ulcerative colitis (UC) is a chronic immune-mediated inflammatory bowel disease (IBD) that almost always affects the rectum and often extends to the more proximal colon. UC usually begins at a young age (15-30 years), most patients (~ 85%) have a mild or moderate activity, characterized by periods of exacerbation and remission. Considering the important pathogenetic role of gut dysbiosis, recently, as an additional method of treating UC, it is considered a modification of altered gut microbiota using various drug and non-drug methods. One such method is fecal microbiota transplantation (FMT), consisting of the simultaneous replacement of the gut microbiota of a sick recipient with fecal material from a healthy donor. Even though so far the only officially approved indication for FMT is recurrent Clostridium difficile infection, however, the effectiveness of FMT is currently being studied in the treatment of other gastrointestinal and non-gastrointestinal pathologies, including UC. To date, several controlled and uncontrolled studies have been conducted to study the effectiveness of FMT in UC, showing encouraging results. This study aimed to assess the clinical and microbiological efficacy, tolerability, and safety of FMT as add-on therapy to basic therapy, in patients with mild-to-moderate UC.
Inflammatory bowel disease consists of ulcerative colitis (UC) or Crohn's disease (CD). The main aim of this study is to describe real-world data on vedolizumab serum concentration and treatment outcomes in cohort of patients treated at the Department of Gastroenterology and Hepatology of University Hospital Center Osijek. Study will be recruiting patients who switched from intravenous to subcutaneous vedolizumab according to routine clinical practice.
What is known? - the impact of AZA, immunomodulatory drug widely used in active CD, on the intestinal wall differs from those of steroids, what is reflected in the significant difference in the postoperative anastomotic leaks rate - AZA inhibits intestinal epithelial cell growth by inducing the apoptosis and inhibiting proliferation of intestinal epithelial cells in in vitro studies What is new? - The effect of AZA on cellular damage was assessed in humans' study - AZA increases cell apoptosis in the intestinal epithelium of active CD patients, much stronger than steroids - AZA actively promotes the DNA damage repair in the intestinal epithelium; the steroid effect, even when combined with AZA, is not so pronounced - The intensity of proliferative processes, in contrast to steroids, is significantly inhibited in response to AZA - The disintegration of the mucosa layer in response to AZA is observed - The difference in the mechanisms of action of AZA and steroids on the intestinal mucosa may be directly related to the reported difference in the risk of septic postoperative complications, but this requires further research
The first prospective randomised placebo-controlled study in the IBD pediatric population was conducted to evaluate the effectiveness of oral sodium butyrate as add-on therapy in IBD.
The prevalence of hepatitis C virus infection (HCV) in patients with inflammatory bowel disease (IBD) ranges from 1-6%. Direct-acting antivirals (DAAs), with cure rates >90%, represent a radical change from interferon-based therapies. The ECCO (European Crohn's and Colitis Organisation) guidelines (Kucharzik T, Ellul P, Greuter T, et al. ECCO Guidelines on the Prevention, Diagnosis, and Management of Infections in Inflammatory Bowel Disease. J Crohn's Colitis. 2021;15(6):879-913) warns about the risk of IBD reactivation due to the effect of DAAs, but HCV management in this situation is uncertain given the lack of evidence. The project is proposed as the largest retrospective multicenter descriptive study carried out to evaluate the use of DAAs for HCV eradication in patients with IBD. The Eneida database (Zabana Y, Panés J, Nos P, et al. The ENEIDA registry (Nationwide study on genetic and environmental determinants of inflammatory bowel disease) by GETECCU: Design, monitoring, and functions. Gastroenterol y Hepatol. 2020;43(9):551-8.) of the Spanish Working Group on Crohn's Disease and Ulcerative Colitis (GETECCU) is an adequate registry to identify patients with HCV infection. The serological status of the infection is frequently recorded in the ENEIDA database, and it is generally evaluated at the time of IBD diagnosis, before starting immunosuppressive treatment. The ENEIDA registry has the advantage over large population studies that researchers have access to relevant details of the clinical history, which can respond to the controversies raised. This multicenter retrospective descriptive study will provide useful information to be able to give evidence-based recommendations regarding treatment of HCV in patients with IBD.
This is a pilot randomized-controlled trial assessing the utility of ondansetron for improving pediatric pre-colonoscopy bowel prep outcomes using the boston bowel preparation score, as well as assessing the impact on patient experience of bowel preparation.
This study aims to test the acceptability and preliminary efficacy of an online intervention (eLIFEwithIBD) developed for people with inflammatory bowel disease (IBD). The eLIFEwithIBD intervention is an adaptation of the LIFEwithIBD program (delivered in an in-person group format; Trindade et al., 2021), being an ACT, mindfulness, and compassion-based intervention. The eLIFEwithIBD intervention comprises nine sessions focusing on education about IBD, the functioning of the mind, emotions, and fatigue; acceptance of internal experiences; willingness; emotion regulation; values clarification; committed action; mindfulness; compassion; and gratitude. These topics are addressed through videos with therapists, texts, and experiential exercises.
This clinical trial is a randomized, double-blind, single-center, placebo-controlled and multiple-dose escalation Pharmacokinetics study
Rationale: Older African Americans undergoing surgery are a vulnerable and growing population at high risk for poor surgical outcomes and disparities. Few programs have focused on this population due to a fragmented understanding of the needs of this population. Objectives: While socioecological determinants of health (SEDOH) such as health literacy and socioeconomic status are known drivers of surgical disparities, an estimated 36-47% of surgical disparities remains unexplained. This gap results from limitations of current clinical datasets in capturing SEDOHs. This pilot study aims to fill this gap by (i) collecting granular SEDOH data, (ii) identifying barriers to surgical care for older African Americans, and (iii) establishing a multi-institutional clinical database through a socioecological context. These findings will help understand how SEDOHs drive surgical disparities and inform development of interventions to eliminate them in elderly African Americans. Design and Methods: Guided by the socioecological model of health, the investigators will use mixed-methods to achieve the objectives. First, the investigators will assess the acceptability and feasibility of a 58-item SEDOH survey based on the NIH PhenX toolkit. After distributing this survey to 36 elderly (≥65 years) African American patients undergoing surgery at 3 rural, UAB-affiliated hospitals (Alex-City, Greenville, Demopolis) the investigators will conduct detailed theory guided assessments of acceptability and feasibility (SA1). Second, the investigators will conduct key informant interviews of individuals from all 5 socioecological levels at each rural hospital (n=10) to identify additional barriers and facilitators to surgical care. The investigators will purposively sample 100% of participants at the patient and caregiver level (n=12) to be elderly African Americans (SA2). Finally, the investigators will link measured SEDOH data with standardized clinical data at each hospital to establish a novel database (SA3). These findings will establish a process to measure SEDOHs across the Deep South and set the foundation for a unique database to study surgical disparities. Significance: Development of effective multilevel interventions to eliminate surgical disparities in older African Americans is dependent on a clearer understanding of the contextual drivers of these disparities. This pilot study will accelerate understanding of these mechanism(s) through SEDOHs. It will establish a process to measure SEDOHs, identify additional barriers to surgical care not captured by NIH instruments, and build the database to study these relationships. Such findings will have the potential to impact vulnerable surgical populations in the Deep South and support the Deep South RCMAR mission to promote health and optimize health outcomes for older and rural African Americans.
Remicade is a common medicine used for the treatment of inflammatory bowel disease. This medication is given as an intravenous infusion over 2 hours. Studies have suggested it is safe to give the infusion at a faster rate. The investigators would like to see if the infusion can be given over 1 hour. The investigators expect that increasing the rate of infusion WILL NOT lead to an increase in infusion reactions and will be just as safe and effective as the standard 2 hours dose.