View clinical trials related to Inflammatory Bowel Diseases.
Filter by:Six sites of the Pediatric Inflammatory Bowel Disease Consortium (plus 2 additional sites) will participate in this study. The participating sites will be that of the Principal Investigator (PI), Emory University School of Medicine, Atlanta, GA (Benjamin D. Gold, MD); Texas Children's Hospital / Baylor College of Medicine (George Ferry, MD and Tony Olive, MD); Children's Hospital of Philadelphia, Philadelphia, PA (Bob Baldassano, MD); University of Chicago Children's Hospital, Chicago, IL (Barbara Kirschner, MD); University of California, San Francisco (Mel Heyman, MD); Mass General Hospital / Harvard University (Harland Winter, MD); V.A. Stanford University School of Medicine, Stanford, CA (David Relman, MD); Children's Center For Digestive Healthcare, Atlanta, GA (Stanley Cohen, MD); and Centers for Disease Control and Prevention, Atlanta, GA (Drs. Jeannette Guarner, Siobhan O'Connor and Thomas Shinnick) The duration of study is 2 yrs. Objectives: 1. Improve the methods to collect biopsies from the colon and ileum, tissue storage techniques and best methods to detect specific infections in children with Crohn's disease; 2. Determine if there are specific infectious agents that are more common in children with Crohn's disease, and; 3. Determine if there are types of children with Crohn's disease (e.g., children living in Boston, African American children) who may be more at risk for getting the infections. The study design involves children ages 6 months through 17 11/12 years of age who are undergoing a clinically-indicated colonoscopy. Subjects will be grouped into cases and controls. - Any child ages 6 mos through 17 11/12 years of age, undergoing a clinically-indicated colonoscopy as determined by the treating physician, is eligible for enrollment. About 500 patients will be enrolled in this study. - Cases will consist of those children within the defined age group, who are undergoing diagnostic colonoscopy and have the definitive diagnosis of Crohn's disease. - Children who have the diagnosis of indeterminate colitis or ulcerative colitis for the purpose of this R03, will be excluded as cases and from initial analysis, but will have tissue specimens banked for subsequent evaluation for infectious agents. - Controls will consists of children within the defined age group, undergoing clinically indicated colonoscopy and who are not diagnosed with Crohn's disease, ulcerative colitis or indeterminate colitis (e.g., juvenile polyps, irritable bowel syndrome or functional bowel disease). - Stool specimen (5ml/1 tsp) will be collected to test for different types of bacteria - A questionnaire will be administered to each research volunteer. - Each subject's medical information (i.e. diagnosis, disease stage, and laboratory results) will be stored electronically in a separate access-based database. A unique identifier will be assigned to each patient entered into the study and will also be used for blinding of the specimens analyzed by the pathologist and by molecular assays for infectious agents. - Colonoscopy will be performed by the treating pediatric gastroenterologist and biopsies obtained in the usual standard of care. - Clinical biopsies from the rectum, left, right, transverse colon and cecum will be placed in formalin containing vials as per standard of care for the clinical pathologist and diagnostic evaluation.
To evaluate the safety and efficacy on clinical symptoms, mucosal histology and endoscopic mucosal appearance of two doses of SR140333B against placebo in patients with mild to moderate ulcerative colitis resistant to treatment with 5-ASA.
An increase prevalence of CMV, EBV and or HHV-6 in diseased tissue of inflammatory bowel disease would suggest a role for these viruses in the etiology and/or exacerbation of IBD, whereas their absence would preclude such association.
Isoprostanes are compounds that are produced as a result of oxidative damage to cell membranes. Elevated tissue, serum, and urinary isoprostane levels have been described in a number of inflammatory diseases. The goal of this study is to determine utility of measuring urinary isoprostane levels in pediatric patients with inflammatory and non-inflammatory gastrointestinal disease. Urine samples will be collected from pediatric patients undergoing procedures in the Children's Hospital endoscopy unit. Clinical disease activity will be assessed using a standardized clinical disease activityiIndex. Gross endoscopic and histologic findings will be graded. Previously obtained laboratory studies will also be recorded. Urinary Isoprostane levels will be determined using a commercially available assay. Isoprostane levels will be compared across conditions (IBD vs. non-inflammatory, Crohn's disease vs. ulcerative colitis) and tested for statistical significance. Similarly, disease severity and urinary isoprostane levels will be assessed. The sensitivity, specificity, and positive and negative predictive values of elevated urinary isoprostane levels at discriminating pediatric patients with inflammatory and non-inflammatory gastrointestinal disease will be calculated.
The investigators hypothesize that PSC in children is associated with mutations and functional changes of the cystic fibrosis (CF) gene.
This randomized placebo-controlled double-blind, multi-centre trial will determine the efficacy of the probiotic VSL#3 in the prevention of Crohn's disease development following surgical resection and re-anastomosis. A total of 120 patients will be randomly assigned in a 1:1 ratio to receive VSL#3 or placebo for 90 days. Patients who respond to study treatment, as defined by the absence of a severe endoscopic recurrence at day 90, will be offered open-label VSL#3 for an additional 9 months.
The purpose of this study is to determine the influence of different 5-aminosalicylate concentrations on the metabolism of azathioprine or 6-mercaptopurine in patients with inflammatory bowel disease.
The hypothesis underlying this study is that nasally administered calcitonin will stabilize or improve bone mineral density in young patients with ulcerative colitis or Crohn's disease. Patients who participate will receive either calcitonin or placebo and will have their bone mineral density measured at the start, at nine months, and at 18 months of study. Participants will also receive age appropriate doses of vitamin D and calcium supplements. Other serological measures of vitamin D status will be obtained every 3 months during the study.
This study will collect tissue specimens to be used for research on inflammatory bowel disease. The tissues will be used to explore why people get inflammatory bowel disease and to try to develop new treatments based on the study results. Tissue from patients with IBD will be compared with that from patients who do not have the disease Patients who undergo bowel surgery for inflammatory bowel disease (IBD) or another bowel disorder may be eligible for this study. Patients with IBD must be at least 4 years of age; those with another disorder must be 18 years of age or older. Participants undergo bowel surgery for their disease. Some of the intestinal tissue removed during the surgery that is not needed for medical care, such as for pathological examination, is provided to researchers for study under this protocol. In addition, patients with IBD provide a blood sample for genetic testing. Several genetic variations, or mutations, may increase the risk of developing IBD; blood samples from patients may help identify these variations.
The purpose of The PROSPECT Study is to evaluate an investigational medication for the treatment of moderate to severe ulcerative colitis. This study is being conducted at up to 38 clinical research centers in the US, Canada, and Belgium, and is open to male and female patients 12 years and older. Participants in the study will have a number of visits to a research center over a five-month period. All study related care and medication is provided to qualified participants at no cost: this includes all visits, examinations, and laboratory work.