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Effects of Prednisolone and Infliximab on the Regulation of Urea Synthesis in Active Inflammatory Bowel Disease

This study has been completed.
Information provided by (Responsible Party):
Karen Louise Thomsen, University of Aarhus Identifier:
First received: August 3, 2009
Last updated: October 11, 2012
Last verified: October 2012

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.

Inflammatory Bowel Diseases

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Effects of Prednisolone and Infliximab on the Regulation of Urea Synthesis in Patients With Active Ulcerative Colitis and Crohn's Disease

Resource links provided by NLM:

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Functional Hepatic Nitrogen Clearance [ Time Frame: Before and one week after treatment ]

Secondary Outcome Measures:
  • Clinical and biochemical measures of inflammation [ Time Frame: Before and one week after treatment ]

Biospecimen Retention:   Samples Without DNA
Serum, plasma and urine.

Enrollment: 40
Study Start Date: January 2009
Study Completion Date: December 2011
Active inflammatory bowel disease
Patients with moderate to severe active inflammatory bowel disease (ulcerative colitis and Crohn's disease)


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with active inflammatory bowel disease seen in the out-patients' clinic or admitted to hospital for treatment.

Inclusion Criteria:

  • Moderate to severe active inflammatory bowel disease

Exclusion Criteria:

  • Viral or bacterial infections
  • Other chronical inflammatory diseases
  • Cancer
  • Other catabolic diseases
  • Treatment with prednisolone or infliximab within the last 8 weeks
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Please refer to this study by its identifier: NCT00955123

Department of Medicine V, Aarhus University Hospital
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Principal Investigator: Karen Louise Thomsen, MD Aarhus University Hospital
  More Information

Responsible Party: Karen Louise Thomsen, Dr., University of Aarhus Identifier: NCT00955123     History of Changes
Other Study ID Numbers: FHNC-KLT
Study First Received: August 3, 2009
Last Updated: October 11, 2012

Keywords provided by University of Aarhus:
Urea synthesis
Nitrogen balance

Additional relevant MeSH terms:
Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents
Dermatologic Agents
Antirheumatic Agents processed this record on May 23, 2017