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Intestinal Diseases clinical trials

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NCT ID: NCT00936585 Terminated - Crohn's Disease Clinical Trials

NIH Substudy of AIN457 (Anti-IL-17 Monoclonal Antibody) for Treatment of Moderate to Severe Crohn's Disease

Start date: July 2009
Phase: N/A
Study type: Interventional

The 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.

NCT ID: NCT00855907 Terminated - Clinical trials for Inflammatory Bowel Disease

Fatty Liver in Inflammatory Bowel Disease (IBD) Patients

Start date: March 2009
Phase:
Study type: Observational

Fatty liver is known to be one of the most frequent liver pathologies in IBD patients (35-40%). Despite this fact, there are only few publications that evaluated the prevalence of fatty liver in IBD patients. Moreover, the pathogenesis of this phenomenon in IBD has not been widely investigated. The paradox of lean patients and fatty liver can be explained by high use of steroids, by rapid weight loss, and by the abundance of TNFα cytokine in IBD patients that causes insulin resistance. The aim of the study: To evaluate the frequency of fatty liver in a cohort of IBD patients and to learn its risk factors. Methods: One hundred consecutive IBD patients treated at the Tel Aviv Sourasky Medical Center will be recruited. Patients will fill up a questionnaire regarding their disease, demographic data, other co-morbidities and medications and risk factors for metabolic syndrome. Each patient will undergo blood examinations in order to assess inflammation, and metabolic status. Fatty liver will be assessed by liver ultra-sonography.

NCT ID: NCT00805285 Terminated - Ulcerative Colitis Clinical Trials

The Use of Oral Budesonide and Rectal Hydrocortisone for the Treatment of Active Ulcerative Colitis

Start date: October 2008
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate if the combination of oral budesonide and rectal hydrocortisone improves symptoms in patients with active ulcerative colitis. Also, we would like to determine if oral budesonide and rectal hydrocortisone has fewer and less severe side effects compared to standard steroids (prednisone).

NCT ID: NCT00591669 Terminated - Clinical trials for Inflammatory Bowel Disease

Non-invasive Imaging of GI Inflammation Using Microbubble Contrast Enhanced Ultrasonography

Start date: May 2006
Phase: N/A
Study type: Interventional

Inflammatory bowel disease (IBD) is a common chronic inflammatory disorder, but a noninvasive method of assessing disease location, severity, and extent is currently not available. Recently published animal data suggests that using transabdominal ultrasound enhanced with encapsulated gaseous microbubbles may provide a reliable, noninvasive means to detect and quantify areas of intestinal inflammation. This study will evaluate the role of Contrast-enhanced ultrasonography (CEU) for use as a diagnostic tool in patients with IBD. We hypothesize that the severity and extent of chronic intestinal inflammation, as quantified by CEU-derived video intensity scores, will correlate with endoscopically-derived measures of intestinal inflammation as obtained from the Crohn's Disease Endoscopic Inflammatory Index (CDEIS). A total of 40 patients will be enrolled in the study, 30 patients with IBD and 10 patients undergoing colonoscopy for other reasons. Prior to colonoscopy CEU assessment of small and large intestine will be performed to evaluate neoangiogenesis and intestinal blood flow. The correlation between the CEU-derived video intensity score and CDEIS will be assessed using Pearson's correlation coefficient. Subjects may also undergo scoring using the Rutgeerts Score, an endoscopic disease assessment index used to score disease activity in patients with previous ileocolonic resection. Comparing video intensity between IBD and non-IBD subjects will be performed using the Wilcoxon rank sum test, with a secondary aim of establishing preliminary estimates of the sensitivity of the microbubble scoring system.

NCT ID: NCT00360022 Terminated - Ulcerative Colitis Clinical Trials

Transition of Inflammatory Bowel Disease (IBD) Patients From Pediatric to Adult Gastroenterologist (GI)

Start date: August 2006
Phase: N/A
Study type: Interventional

The purpose of this study is to determine if the program that has been made to ease the transition of care for adolescent patients with IBD from pediatric gastroenterology to adult gastroenterology is effective to reduce the risk of disease flare during this period. Patient satisfaction with this program will also be assessed.

NCT ID: NCT00325078 Terminated - Clinical trials for Chronic Granulomatous Disease

Infliximab to Treat Crohn'S-like Inflammatory Bowel Disease in Chronic Granulomatous Disease

Start date: May 2006
Phase: Phase 1/Phase 2
Study type: Interventional

This study will determine if the drug infliximab is safe for treating inflammatory bowel disease (IBD) in patients with chronic granulomatous disease (CGD). IBD is an inflammation or irritation of the gut that leads to symptoms such as diarrhea, bloating and stomach cramps. CGD is an inherited disease affecting white blood cells called neutrophils in which patients are susceptible to repeated bacterial and fungal infections. They also have a higher incidence of some autoimmune diseases, such as IBD. Infliximab is approved to treat Crohn's disease, an IBD similar to that seen in patients with CGD. Patients 10 years of age and older with CGD and IBD may be eligible for this study. Candidates are screened with a medical history, physical examination, blood and urine tests, electrocardiogram (EKG), tuberculosis skin test (PPD skin testing), and stool test for the presence of infections. Additional tests may be done, including colonoscopy (procedure using a flexible tube through the rectum to examine the lining of the gut) and imaging studies such as an x-ray, chest CT scan (test using a special x-ray machine), MRI (test using a magnetic field and radio waves), and barium studies (study using a drinkable solution of barium to help enhance the x-ray pictures of the gut). Participants are divided into patients with IBD symptoms (Group 1) and patients without IBD symptoms (Group 2) for the following procedures: Group 1 Patients are evaluated every 6 months with a medical history and physical examination for signs and symptoms of IBD. Patients who are taking moderate to high doses of steroid medications have their medication slowly lowered (tapered) and are evaluated every 3 months for a total of 2 years. Patients in this group who start to develop IBD symptoms are moved to Group 2 for treatment with infliximab (see below). Group 2 Patients in Group 2 receive infliximab infusions at 2-week intervals for three doses. The drug is given over a 2-hour period through a catheter placed in a vein. Patients are evaluated with a medical history, physical exam, and blood tests the day of each dose. One week after the last dose, they have another evaluation, including a colonoscopy. Patients who respond well to infliximab may continue to receive the drug every 2 months for a total of 1 year, with evaluations at every dosing visit. At the end of the first year of receiving infliximab, all patients have follow-up evaluations every 6 months for a total of 2 years. Group 3 Subjects who volunteer to undergo colonoscopy and research biopsies that serve as controls for evaluation of the patient gut samples.

NCT ID: NCT00237653 Terminated - Clinical trials for Inflammatory Bowel Diseases

MICI-CMV:Valganciclovir in Recurrent Bouts of Cryptogenic Inflammatory Bowel Diseases With an Infection by Cytomegalovirus

Start date: February 2004
Phase: Phase 3
Study type: Interventional

The main objective of this study is to demonstrate the relevance of Valganciclovir on recurrent bouts of cryptogenic inflammatory bowel diseases with infection by cytomegalovirus (CMV). The goal is to obtain 90% (for Valganciclovir treated patients) versus 50% (for placebo treated patients) remission at 3 months (including the discontinuation of corticoids or reducing their dose to under 20 mg of prednisone equivalence), without any relapse over the 6 following months.

NCT ID: NCT00205062 Terminated - Clinical trials for Inflammatory Bowel Diseases

Positron Emission Tomography (PET)-Computed Tomography (CT) in Inflammatory Bowel Disease (IBD)

Start date: October 2004
Phase: Phase 4
Study type: Interventional

The main hypothesis is that PET-CT will be a valuable diagnostic tool in diagnosing and evaluating treatment for IBD.

NCT ID: NCT00152620 Terminated - Clinical trials for Inflammatory Bowel Disease (IBD)

Dexamethasone Versus Methylprednisolone for the Treatment of Active Inflammatory Bowel Disease

Start date: June 2004
Phase: N/A
Study type: Interventional

The aim of this therapeutic trial is to compare the response of subjects with active IBD to daily intravenous dexamethasone versus the response to daily intravenous methylprednisolone.

NCT ID: NCT00001162 Terminated - Cryptosporidiosis Clinical Trials

Parasitic Infections of the Gastrointestinal Tract

Start date: May 23, 1977
Phase: N/A
Study type: Observational

This protocol offers diagnosis and standard medical treatment for various parasitic gastrointestinal infections. Gastrointestinal parasites are either worms (helminths) or one-celled animals called protozoans which live in the human intestines. Often, parasitic infections do not cause illness. In these cases, drug treatment is not indicated, because treatment can have adverse side effects. Patients will be examined for their immune responses, correlation between the number of parasites and disease, and other studies. Individuals with known or suspected parasitic diseases of the gastrointestinal tract, including amebiasis, giardiasis, hookworm, strongyloidiasis, trichuriasis, pinworm, tapeworm, trichinosis, clonorchis, opisthorchis, coccidiosis, paragonimiasis, and echinococcus may be eligible for this study. Patient evaluations may include blood and urine tests, stool examination, X-rays, ultrasound studies and, uncommonly, duodenal aspiration for examination of fluid from the duodenum (first part of the small intestine). Other tests may be required, depending on the parasite and disease. Direct examination of the tissues of the intestines may be required to rule out certain infections. Research procedures include collection of stool, blood and duodenal fluid when the diagnosis has been established and these procedures are not required for medical care. Patients with strongyloidiasis may also be given a diagnostic skin test similar to skin tests for tuberculosis and allergies. Research procedures on children will be limited to collection of stool, urine and blood. No more than 7 milliliters (1 1/2 teaspoons) per kilogram (2.2 pounds) body weight of blood will be collected in children over a 6-week period. In adults no more than 30 tablespoons of blood will be collected in a 6-week period. Parasites may fail to respond to treatment. In these cases, it may be necessary to grow the parasite in the laboratory in order to test treatments in the test tube. Patients who do not respond to standard medications and dosing may need different doses of drugs or drugs or combinations of drugs used in the United States for other medical problems. If these medications or doses are used, patients will be informed of their possible side effects.