Inflammatory Bowel Disease(IBD)Database
Inflammatory Bowel DiseaseThis will be a comprehensive epidemiological, clinical, endoscopic and histological database for inflammatory bowel diseases patients in our medical center that will further provide clinical and basic investigations.
Managing Inflammatory Bowel Disease
Inflammatory Bowel DiseaseCrohn's Disease1 moreInflammatory Bowel Disease (Crohn's disease and ulcerative colitis) often results in significant life disruption, hospitalization and surgery. While psychosocial factors are not believed to cause IBD, such factors can contribute to the ability of individuals with IBD to cope with the disease, and ineffective coping may lead to the exacerbation of IBD symptoms. The goal of this study is to evaluate the efficacy of a social learning and cognitive behavior therapy approach for treating children with IBD. The primary outcomes of interest are IBD symptoms, medical visits, quality of life, and overall disability.
NIH Substudy of AIN457 (Anti-IL-17 Monoclonal Antibody) for Treatment of Moderate to Severe Crohn's...
ColitisCrohn's Disease1 moreThe objective of this NIH-specific substudy is immunologic monitoring of cytokine and immune cell responses in subjects undergoing treatment with AIN457 (human monoclonal anti-human interleukin-17A) for moderate to severe Crohn's disease. Recent data suggests that interleukin-17 (IL-17) is an important mediator of inflammation in certain animal models of Crohn's disease, and treatment aimed at blocking the IL-23-IL-17 axis can ameliorate the inflammatory changes. In addition, elevated expression of IL-l7 has been found in the gut tissue of patients with active Crohn's disease. This substudy will measure changes in cytokine production, relevant RNA expression, and immune cell populations (in the periphery and lamina propria) for correlation with clinical outcomes in order to explore the mechanisms of therapeutic response.
Safety and Efficacy Study of Oral Ferric Iron To Treat Iron Deficiency Anaemia in Quiescent Crohn's...
Iron Deficiency AnaemiaInflammatory Bowel Disease1 moreThe purpose of this study is to determine whether ST10-021, an oral ferric iron preparation, is safe and effective in the treatment of iron deficiency anaemia (IDA) in subjects with non-active Crohn's Disease (CD).
Spinal Analgesia for Colonic Resection Using an Enhanced Recovery After Surgery (ERAS) Program
Colon CancerInflammatory Bowel Diseases1 moreThis is a blinded randomized controlled trial in patients undergoing laparoscopic colon surgery. The aim of this study is to assess whether spinal analgesia with a mixture of bupivacaine and morphine provides better pain relief than systemic morphine in a group of patients undergoing colonic resection and using the Enhanced Recovery After Surgery (ERAS) program. Twenty patients will receive spinal analgesia and twenty patients will receive only Patient Control Analgesia (PCA).
Efficacy and Safety of Adipose Stem Cells to Treat Complex Perianal Fistulas Not Associated to Crohn´s...
Anal FistulaAnal fistula is defined as an abnormal communication between the anal canal and the perianal skin. Adipose-derived stem cells are a new therapy for the closure of these fistulas. This study will test the safety and efficacy of ASCs (adipose stem cells) in the treatment of patients without Crohn´s disease.
Nolpitantium Besylate In Patients With Ulcerative Colitis a Double-Blind, Placebo Controlled Efficacy...
Ulcerative ColitisInflammatory Bowel DiseaseTo 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.
The Influence of 5-Aminosalicylates on Thiopurine Metabolite Levels
Crohn's DiseaseUlcerative Colitis1 moreThe 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.
A Trial of Rosiglitazone for Ulcerative Colitis
Ulcerative ColitisInflammatory Bowel DiseaseThis is a multicenter, randomized, double-blind, placebo-controlled study evaluating rosiglitazone: 4 mg tablets or placebo tablets administered orally twice daily for 12 weeks. The purpose of the study is to evaluate the efficacy and safety of rosiglitazone in the treatment of mild to moderately active ulcerative colitis. Disease activity will be measured using a standard disease activity index. Calculation of the index requires patients to undergo flexible sigmoidoscopy at the start of the study and at week 12.
Stress and Personality Profiles in IBD
Inflammatory Bowel DiseaseMain aim is to evaluate the role of stress in the evolution of inflammatory bowel disease (IBD) and the quality of life of these patients. A second aim is to establish the existence of any psicopathological profile in these patients. We designed a prospective experimental study were patients are randomized to receive or not a cognitive-behavior program. Patients will be evaluated at 3 and 12 months after the program and study variables will be measured: stress level, coping strategies, quality of life, activity of disease and biological variables related to IBD.