View clinical trials related to Intestinal Diseases.
Filter by:Summary 1. Purpose and Objective: The purpose of this study is to test the feasibility of rapid acquisition of point of care 3D ultrasound in obtaining abdominal and/or pelvic images. The study will use a newly developed acquisition method and post-processing technique to create three dimensional image models of the abdomen and/or pelvis. 2. Study activities and population group. The study population will be a convenience sample of patients of any age presenting to the Emergency Department with complaints necessitating a clinical abdominal and/or pelvic imaging. The study intervention includes acquisition of research ultrasound images, which will not be used for clinical care, and comparison of these images with clinically obtained images. Other clinical data such as surgical and pathology reports will also be reviewed. 3.Data analysis and risk/safety issues. This is a pilot study intended to determine feasibility and to refine image reconstruction algorithms. Research images will be compared to clinical images. Comparison of research images with final diagnosis will also occur. The research intervention, an ultrasound exam, has no known safety risks. The only risk to subjects is loss of confidentiality. This study is observational, not interventional, because the experimental ultrasound will be performed in all subjects and will not be used in the clinical care of patients (consequently, will not have the opportunity to affect clinical outcomes). Experimental images will be reviewed after completion of clinical care and will not be provided to the clinicians caring for the subjects. The investigators are not measuring the effect of the ultrasound examination on the subjects' outcomes.
The purpose of this study is to gather information regarding the population with moderate to severe inflammatory bowel disease (IBD), the burden of the disease, and understand their treatment patterns, particularly on the use of available biologic therapies.
Individuals with IBD are at risk for nutrient deficiencies. This prospective, non-randomized, open-label study will assess the effect of a nutrition support product on nutritional status in adults with IBD. Up to ten adults with ulcerative colitis or Crohn's disease will be enrolled in the study and asked to take the product for 12 weeks. The primary measures of the study are several blood markers of nutritional status.
The purpose of this study is to assess the effectiveness of a supplement with natural Mastiha on Inflammatory Bowel Diseases (IBD). U.S. Food and Drug Administration has classified Mastiha as GRAS. Previous research demonstrates Mastiha's safety, as well as anti-inflammatory, antimicrobial and antioxidant properties. In addition, the European Medicine Agency has recently recognized Mastiha as a natural medicine and classified it to the category of traditional herbal medicines in diarrhea problems, mild dyspeptic disorders, skin inflammation and healing (EMA/HMPC/46758/2015). Since IBD is a chronic disease characterized by inflammation and oxidative stress and based on previous small-scale studies, the present study aims at demonstrating the effectiveness of this supplement adjunct to the conservative treatment of IBD. To this end, confirmed IBD patients, with distinguished Ulcerative Colitis (UC) and Crohn's Disease (CD) will be enrolled based on certain inclusion and exclusion criteria. The staff of the study will provide detailed information regarding the aims, the methods, anticipated benefits and potential hazards of the study and all patients will receive the Patient Information Leaflet (PIL). Ample time (48 hours) will be provided in order to decide whether they want to participate in the protocol. Each patient agreeing to participate will sign an Informed Consent document and the staff will explain to patients that they are under no obligation to enter the trial and that they can withdraw at any time during the trial, without having to give a reason. A copy of the signed Informed Consent will be given to the participant. 100 IBD patients will be allocated to either Mastiha or placebo group. The Mastiha group will receive natural Mastiha supplement at a dose of 2.8 g daily while placebo group will receive respectively placebo. The intervention will last 3 months for patients in relapse and 6 months for patients in remission. They will receive all the supplements they will consume during the intervention at the start of the trial. Both groups will continue their medical treatment, which must be unaltered throughout the trial. Additionally, all patients will receive standard nutritional advice by dieticians and will be encouraged to report any adverse effects they may experience during the intervention. The trial will be blinded in all implicated persons; neither the staff of the trial nor the patients will be aware of which kind intervention they receive. Patients are assessed after randomisation according to the following tools: - Medical history - Dietary history - Harvey & Bradshaw Activity Index Assessment - Mayo Activity Index assessment - Anthropometric data measurement: body weight (kg), height (cm), Body Mass Index (kg/m2) - Inflammatory Bowel Disease Questionnaire - DNA isolation from whole blood. - Biochemical measurements: Complete blood count, albumin, lipid profile, glucose, electrolytes, liver enzymes, amylase, fibrinogen. - Evaluation of inflammation in serum samples. Circulating serum levels of IL-6, IL-8, IL-17A, IL-17F, IL-18, IL-21, IL-22, TL1A, TGF-β, ICAM-1, MADCAM-1 and E-selectin are measured), in all active CD and UC patients. Inflammatory markers are also estimated in stool samples: calprotectin, lactoferrin and lysozyme, - Oxidative stress assessment in serum/plasma samples. Oxidised LDL, serum oxidisability and F2-isoprostanes are quantified. - Detection of metabolites and complete metabolomic profile in plasma samples. - Stool samples collection for the assessment of gut microbiota in active patients. - Genetic and epigenetic profile Subsequent assessments: There is a biweekly telephone contact with the patients to monitor compliance and side effects. At the end of the intervention each subject undergoes the baseline assessment.
The purpose of this study is to measure IL-6 and IL-6/sIL-6R complex levels in subjects with active moderate to severe ulcerative colitis or Crohn's disease.
This study evaluates the impact of Endorings™ assisted colonoscopy on the number of polyps detected per patient compared to standard colonoscopy without use of EndoRings™. Half of the participants will receive EndoRings™ assisted colonoscopy, while the other half will receive standard colonoscopy.
When women with rheumatoid arthritis become pregnant 75% of them will go into remission, despite stopping medication. This phenomenon is not well understood and is not seen in other inflammatory conditions. Once they give birth they often relapse. Bacteria in the stool and inside the gut have the ability to effect the immune system and some beneficial bacteria are known to down regulate inflammatory components of the immune system. Gut bacteria are also known to alter significantly during pregnancy and in other inflammatory conditions there are low levels of beneficial bacteria associated with diseases like ulcerative colitis. There is significant crossover between rheumatoid arthritis and inflammatory bowel disease with similar arthritic symptoms and mechanisms of inflammation. There is very limited investigation of gut bacteria and rheumatoid arthritis, but some animal work has shown that treatment with probiotics and prebiotics can improve the condition. The aim of this study is to examine the bacteria in the stool of women who are pregnant with rheumatoid arthritis and identify any significant bacteria changes that might be used to direct future research.
There are many forms of small bowel disease but their direct consequences on small bowel function are often very hard, if not impossible, to establish. It would be helpful if there was a reliable blood test to find out how well cells in the intestine are working. The amino acid citrulline is produced mainly by these cells, and therefore holds promise as a biological marker. Some previous studies have shown that fasting citrulline gave a good indication as to how many intestinal cells were present. However, other authors have not been able to confirm this. Most of the citrulline in the blood is derived from another amino acid, glutamine, in a metabolic process that occurs in the intestinal cells, and most of the remainder comes from another amino acid, arginine. A further potential marker of intestinal cell function is the amino acid 3-methylhistidine. It is possible that a dynamic test, which incorporates time for conversion from one amino acid to another in the intestinal cells, might perform better. The investigators therefore propose a study of oral glutamine, arginine, and 3-methylhistidine compared with citrulline itself or placebo (glucose) as it is hypothesized that these might increase the amount of citrulline more reproducibly. An initial study in healthy subjects is required to establish whether this is true, and if so to provide a normal range prior to investigation of patients who have or who might have the short bowel syndrome, and in whom the test would be clinically useful. In this study, the subjects will take each of the amino acids and placebo in random order. Between each 6 hour-long visit the subjects will have at least one week where they are independent of the research team and during which they can behave normally. During each visit subjects will have a sequence of blood samples from an in-dwelling venous cannula, taken before and over 6 hours after a single small oral dose of that day's amino acid given as a small volume drink. Urine will also be collected for amino acid assay.
Fatigue is a common symptom in inflammatory bowel diseaseI and persists despite clinical remission. Fatigue in patients with chronic diseases can be objectified by the FACIT-F scale. Acupuncture has been shown useful in the treatment of fatigue in various chronic diseases. This study evaluates the effect of electroacupuncture in the treatment of fatigue in patients with quiescent inflammatory bowel disease. Patients with inflammatory bowel disease and severe fatigue (FACIT-F score <38) who agree to participate in the study will be randomized to three different treatments: electroacupuncture vs. sham electroacupuncture vs. control group.
The IBSEN III study will investigate the incidence of inflammatory bowel disease in South Eastern Norway and describe the clinical course of the disease. The investigators will map newly diagnosed and treatment naive IBD patients at various levels (epidemiological, clinical, psychosocial and nutritional as well as immunological, genetic, epigenetic and microbial) as a basis to improve targeted and individualized treatment and care. The investigators will include incident IBD patients at all local- and university hospitals in the South Eastern Health Region in 2016-2018 and follow-up prospectively for five years. The investigators will use standardized and validated registration methods allowing comparability with previous national and international IBD cohorts, link data to national health registries and collect blood, feces and biopsies for bio banking.