View clinical trials related to Intestinal Diseases.
Filter by:This study will test whether it is feasible to conduct a clinical trial of mirtazapine (an antidepressant tablet) in patients who have both depression and inflammatory bowel disease (IBD). The study design is a randomised controlled trial (a study in which people are allocated by chance to receive different interventions). The trial will compare mirtazapine against a placebo (dummy) tablet in 76 patients with both depression and IBD. The investigators will recruit outpatients aged 18 or over with a diagnosis of any IBD attending gastroenterology clinics. Either in person or remotely, patients will complete a brief screening questionnaire for depression. Those scoring positive for depression will be invited for a 15-minute interview for clinical depression. Those with clinical depression will be invited to take part. Participants will be randomly allocated by a computer to take either 1) mirtazapine tablet once at night for 12 weeks; or 2) placebo (dummy) tablet once at night for 12 weeks. The study is 'blinded', meaning neither patients nor the study team will know which medication they are taking. Throughout, participants will be able to access other treatments for depression, such as talking therapies. The investigators will measure how many people join the study; how many remain in the trial; how many complete treatment; how many tablets people take; and assess overall acceptability of the trial. Participants will complete brief questionnaires to measure their mental health and IBD symptoms after 4 weeks, 8 weeks, 12 weeks and 16 weeks. Participants will also provide blood samples and faecal samples to measure inflammation. If successful, this trial will support an application for a larger version of the study.
This study aims to determine if improved risk stratification tools and interventions to mitigate malnutrition reduce postoperative risk in patients undergoing elective or emergent resection surgery for inflammatory bowel disease (IBD), and if adding immune modulation nutrition improves surgical outcomes. The primary objective is to assess whether preoperative malnutrition screening and intervention minimize postoperative complications. The secondary objective is to evaluate whether immune modulation nutrition in the peri-operative period decreases length of stay and major complications.
The goal of this clinical trial is to compare induction treatment with CT-P13 SC to induction treatment with CT-P13 IV in terms of pharmacokinetics in adult patients with inflammatory bowel disease (IBD) who have been diagnosed for at least 3 months and for whom the physician has decided to initiate treatment with infliximab CT-P13 as part of the standard of care. The main aim of this study is to demonstrate that induction treatment with CT-P13 SC is non-inferior to CT-P13 IV in terms of pharmacokinetics at Week 6.
The objective of this randomized, double-blind, placebo-controlled study is to evaluate the effectiveness of Skal Pro in alleviating symptoms, enhancing stool consistency, improving quality of life, and addressing psychological distress in individuals diagnosed with irritable bowel syndrome (IBS), as compared to those who receive no intervention.
The CELESTE cohort will be a three-center prospective cohort associated with the creation of a biobank including Inflammatory Bowel Diseases (IBD) patients with active disease
The study aims to determine if defecation posture, when using a defecation posture modification device (DPMD), will improve ease of bowel movements in patients with pelvic organ prolapse, specifically rectoceles.
Inflammatory bowel disease (IBD) is a chronic and recurrent inflammatory disease of the gastrointestinal tract characterised by complex interactions between genetic susceptibility, environmental factors, microbiota and host immune response. It has two main forms, Crohn's disease (CD) and Ulcerative colitis (UC). The main mechanism of IBD pathogenesis is dysregulated host immune response to commensal microbiota and disruption of the balance of pro- and anti-inflammatory cytokines in genetically predisposed individuals. Periodontitis is a multifactorial inflammatory disease associated with dental biofilm resulting in the loss of periodontal supporting tissues and subsequently teeth. Although the occurrence of the disease depends on multifactorial factors, bacterial plaque is the primary etiological factor and various bacterial species found in plaque are responsible for initiating and maintaining the inflammatory and immune response in periodontal disease. Periodontal diseases are known to contribute to many systemic diseases/conditions or systemic disorders are known to affect periodontal disease. Although the relationship between IBD and periodontitis is based on the potential link between oral and intestinal microbiomes and host immunoinflammatory response, the pathological interactions between the two diseases have not yet been determined. From this point of view, the aim of our study was to investigate the effect of periodontal status on serum, saliva and gingival biomarkers (TIM-3, TNF-α, IL-6 and IL-17) in patients with IBD and to evaluate the relationship between these values and periodontal clinical parameters. This is the first study to examine TIM-3 levels in saliva, serum and gingival samples in patients with IBD and periodontitis with IBD.
This multi-center study will evaluate the safety and immune response to recombinant zoster vaccine (RZV) series in 264 patients with inflammatory bowel disease (IBD) on immunosuppressive therapy recruited from 6 study sites who can expect to be on study for up to 14 months.
The aim of this observational study is to identify the social and demographic determinants of fatigue in patients with inflammatory bowel disease in remission. Secondly, the objectives of the study are to: - Assess the impact of fatigue on the quality of life of patients with inflammatory bowel disease in remission. - To determine the profile of patients with inflammatory bowel disease in remission who are fatigued. To this end, during a consultation or hospitalization, participants will be asked to respond independently to various questionnaires (FACIT-F, DIPCare, SSQ6, questionnaire on socio-demographic determinants and IBD disk). Characteristics of the type of chronic inflammatory bowel disease will be collected from medical records. There will be no patient follow-up as part of the study. Participants may be contacted by telephone by the center's investigator within 2 weeks of the interview in the event of a partial or imprecise response.
Crohn's disease and Ulcerative Colitis, collectively known as Inflammatory Bowel Disease (IBD), impose a significant burden on patients and healthcare systems due to their chronic nature and complex treatment. This study aims to assess the effectiveness and safety of on-demand telemonitoring, as opposed to standard fixed-schedule telemonitoring, in managing IBD. The primary objective is to evaluate the impact of on-demand telemonitoring on the number of persistent flares over 12 months. The study involves a multicenter randomized controlled trial comparing standard telemonitoring, which includes regular completion of the Monitor IBD At Home questionnaire and fecal calprotectin home tests, with on-demand telemonitoring where patients use the app based on their symptoms. The study population includes adult patients with stable remission on maintenance therapy. Disease activity, measured by unplanned healthcare contacts, is the primary outcome, while secondary outcomes encompass clinical and patient-reported disease activity, quality of life, self-efficacy, patient activation, total healthcare contacts, safety, and costs. Baseline characteristics include patient, disease, and socio-demographic factors. This innovative approach has the potential to enhance patient autonomy, satisfaction, and self-management, while reducing the overall burden on the healthcare system.