Active clinical trials for "Inflammatory Bowel Diseases"

Abdominal pain is a common symptom in patients with inflammatory bowel disease (IBD). Up to 70 % of IBD patients experience pain when the disease is active. Even when patients with IBD are in remission, 20-50 % experience ongoing pain. The precise mechanism of developing chronic abdominal pain in patients with IBD in remission remains unknown. The aim of this study is to identify psychophysiological and biological risk factors for the development of chronic abdominal pain in patients with newly diagnosed IBD (ulcerative colitis and Crohn's disease). This study consists of 4 sections (Study 1A, 1B, 2, and 3): Study 1A: We perform a longitudinal study in 150 patients with new-onset IBD over 18 months to identify risk factors related to the brain-gut axis for the development of chronic pain. This is a collaborative study with IBD BioResourse Inception study. We administer online questionnaires, collect stool and blood samples, and record heart rate. Other physiological data collected by the Inception study will be also used for the analysis. Study 1B: This is also a collaborative study with the Inception study. We will apply for our detailed questionnaires for 7 days (as per study 1A) to be administered to all the new patients (n=450) that are included in the Inception study on a voluntary basis. Patients will be followed for 12 months. Study 2 and 3: Study 2 and 3 are a questionnaire-based cross-sectional study in patients with IBD. The participants for study 2 are patients registered in IBD BOOST study and those for study 3 are patients registered in IBD BioResource (but not in IBD Boost study). Detailed online questionnaires will be administered to them. These studies are just one-day assessment.

In this study it will be explored whether the levels of fecal biomarkers are associated with histologic inflammation of the intestinal mucosa and concomitant alteration of the mucosal permeability. The aim of the study is to assess the diagnostic accuracy of fecal biomarkers especially to detect the potential of differentiation between inflammatory and functional gastrointestinal diseases. The following biomarkers will be examined in the stool of the participants: calprotectin, lactoferrin, pmn-elastase, human beta-defensin, zonulin, alpha-antitrypsin.

The human intestinal microbiota is composed of complex community of 10*13 to 10*14 commensal microorganisms[1]. Human intestine provides a nutrient-rich habitat for intestinal microorganism which allows a diverse ecosystem to enhance their host's immune system and facilitate digestive activities. Numerous researches are investigating the role of gut microbiota in human homeostasis, which may be related to the pathogenesis of gastrointestinal disease and autoimmune disorder. Fecal microbiota transplantation (FMT) is defined as infusion of feces from healthy donors to affected subjects. FMT works by altering the patient's microbiome and it is now recommended as an effective therapy for Clostridium difficile infection (CDI) not responding to standard therapies[8]. It has attracted great interest in recent years and many researches are exploring the FMT's potential role for treating other gastrointestinal disease such as IBD. A FMT registry is required to explore the relationship between disease prognosis and intestinal microbiota.

Symptoms such as fatigue, sleep disturbances, anxiety and depression are common in patients with IBD, but the cause is unknown. Understanding how these behaviors occur in IBD and their role in symptoms may help improve management of IBD. How IBD leads to changes in brain function remains unclear. Inflammation and dysfunction of blood flow may occur in patients with IBD, which may be linked to these symptoms. Patients with IBD also have an alteration or imbalance of gut bacteria which may play a role in the development of the disease, but the exact mechanism remains poorly understood;as a result, there are limited therapeutic options available clinically to address this issue. An approved therapy, anti-TNF α, may be useful in improving brain and gut activity as well as quality of life. The purpose of this research study is to better understand brain and gut activity in the context of IBD to possibly improve treatments for the disease. In patients taking anti-TNFα therapy as prescribed clinically as standard of care, the investigators will measure brain activity using NIRS; gut microbiome using stool analysis and quality of life using various questionnaires.

The MUSIC study is a multi-centre, longitudinal study set in the real world IBD clinical setting to investigate and develop a new biomarker approach that aims to inform both patients and clinicians of the current state of the affected gut lining (how inflamed or whether the bowel wall has completely healed). This new biomarker approach will study a panel of molecular signs in IBD patients' blood, stools and biopsies that will be correlated to the current gold standard of direct gut visual examination using ileo-colonoscopy and flexible sigmoidoscopy tests (a fibre-optic examination of the lower small bowel and large bowel). Here, the state and appearances of IBD patients' gut lining will be assessed over one year in response to treatment given to them by their NHS IBD consultant. This approach will focus on the role of damage associated molecular patterns (DAMPs), also known as 'danger signals'. DAMPs are found in our own cells and are released during tissue stress or injury. Like signals from bacteria, they can trigger inflammation. In the MUSIC study, blood, stool, saliva and gut samples obtained from participants during active IBD and in clinical remission will be used in order to understand how DAMPs contribute to the development of gut inflammation.

In this study, participants with ulcerative colitis or Crohn's disease or pouchitis will be treated with Kynteles injection (Vedolizumab) according to their clinic's standard practice. The main aim of the study is to check for side effects from treatment with Kynteles injection (Vedolizumab). Another aim is to learn how many participants have improved symptoms after treatment with Kynteles injection (Vedolizumab).

This study is carried out in patients with IBD and healthy subjects requiring ileocolonoscopy as part of routine care (disease monitoring or polyp/colon cancer screening). It aims the generation and culturing of organoids from digestive biopsies recovered from healthy and/or pathological (inflammatory) ileal and/or colonic mucosa during an ileo-colonoscopy. These cultures will make it possible to validate the organoid production method used in the context of the research (primary objective). In a second phase (secondary objectives), the study will aim to setup a screening tool by irradiating the organoids (step one) and then evaluate in vitro the regenerative activity of treatments dedicated to improve inflammatory bowel diseases and acute radiation enteritis (step two).

UC is a chronic, idiopathic form of intestinal inflammatory disease (IBD) that affects the colon, most commonly afflicting adults aged 30-40 years and resulting in disability and lower quality of life (1). It is characterized by relapsing and remitting mucosal inflammation, starting in the rectum and extending to proximal segments of the colon. Although biologic therapies have provided clinical benefits to patients, these goals are still poorly met, due to the limited knowledge of the underlying mechanisms of immunopathology and the lack of predictive biomarkers that would allow proper patient stratification. The hypothesis of this study is that by identifying new biomarkers in blood, stool and tissue that (i) predict response (or non-response) to therapy prior to the start of treatment and (ii) predict response to therapy in the early phase of treatment will allow to find the right treatment for the right patient (personalized medicine).

this study aims to determine the effect of 8 weeks of exercise on the quality of life and muscle strength of patients with IBD. Patients will be randomized into 1) Intervention group: doing aerobic and resistance exercise according to physiotherapist prescription and 2) Control group: usual medical care. Both groups will continue their medications prescribed by the Gastroenterologist. After 8 weeks patients come back to the hospital for reevaluation of measured indices. The primary outcome of this study is the patient quality of life assessed by the IBDQ questionnaire. Other outcomes that will be evaluated before and after 8 weeks are muscle strength measured by a dynamometer and laboratory markers such as ESR and CRP and tool calprotectin. Also, disease activity using partial mayo score and Harvey Bradshaw score will be calculated and compared before and after treatment.

The purpose of the study is to determine if a plant-based resistant starch that is optimized for the individual will target the underlying cause of inflammatory bowel disease and restore a "healthier" gut microbiome in pediatric participants with inflammatory bowel disease.