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| Sponsored by: |
University of Aarhus |
|---|---|
| Information provided by: | University of Aarhus |
| ClinicalTrials.gov Identifier: | NCT00955123 |
Purpose
Loss of total mass of muscles (catabolism) is a serious clinical problem in patients with active inflammatory bowel disease (IBD). The investigators have earlier shown that the liver plays an important role in this stress-catabolism by increasing the production of urea during the inflammatory process.
The purpose of this study is to examine the effect of the anti-inflammatory drugs prednisolone and infliximab on the regulation of the urea synthesis in patients with active ulcerative colitis and Crohn's disease.
| Condition |
|---|
|
Inflammatory Bowel Diseases |
| Study Type: | Observational |
| Study Design: | Case-Crossover, Prospective |
| Official Title: | Effects of Prednisolone and Infliximab on the Regulation of Urea Synthesis in Patients With Active Ulcerative Colitis and Crohn's Disease |
Serum, plasma and urine.
| Estimated Enrollment: | 40 |
| Study Start Date: | January 2009 |
| Groups/Cohorts |
|---|
|
Active inflammatory bowel disease
Patients with moderate to severe active inflammatory bowel disease (ulcerative colitis and Crohn's disease)
|
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Patients with active inflammatory bowel disease seen in the out-patients' clinic or admitted to hospital for treatment.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Karen Louise Thomsen, MD | +45 89493897 | karethom@rm.dk |
| Denmark | |
| Department of Medicine V, Aarhus University Hospital | Recruiting |
| Aarhus, Denmark, 8000 | |
| Contact: Karen Louise Thomsen, MD karethom@rm.dk | |
| Principal Investigator: Karen Louise Thomsen, MD | |
| Principal Investigator: | Karen Louise Thomsen, MD | Aarhus University Hospital |
More Information
| Responsible Party: | Department of Medicine V, Aarhus University Hospital ( Karen Louise Thomsen ) |
| Study ID Numbers: | FHNC-KLT |
| Study First Received: | August 3, 2009 |
| Last Updated: | August 5, 2009 |
| ClinicalTrials.gov Identifier: | NCT00955123 History of Changes |
| Health Authority: | Denmark: The Regional Committee on Biomedical Research Ethics |
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Inflammation Urea synthesis Catabolism Nitrogen balance |
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Anti-Inflammatory Agents Crohn's Disease Gastrointestinal Diseases Infliximab Methylprednisolone Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Inflammatory Bowel Diseases Prednisolone acetate Hormones Methylprednisolone Hemisuccinate Antineoplastic Agents, Hormonal Ileitis |
Ulcer Enteritis Methylprednisolone acetate Colitis, Ulcerative Intestinal Diseases Glucocorticoids Inflammation Digestive System Diseases Crohn Disease Prednisolone Gastroenteritis Colitis |
|
Anti-Inflammatory Agents Antineoplastic Agents, Hormonal Antineoplastic Agents Gastrointestinal Diseases Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Inflammatory Bowel Diseases Intestinal Diseases |
Glucocorticoids Hormones Pharmacologic Actions Digestive System Diseases Therapeutic Uses Prednisolone Gastroenteritis |
