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
ClinicalTrials.gov 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical and biochemical measures of inflammation [ Time Frame: Before and one week after treatment ] [ Designated as safety issue: No ]

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
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov 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

No publications provided

Responsible Party: Karen Louise Thomsen, Dr., University of Aarhus
ClinicalTrials.gov Identifier: NCT00955123     History of Changes
Other Study ID Numbers: FHNC-KLT 
Study First Received: August 3, 2009
Last Updated: October 11, 2012
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:
Urea synthesis
Nitrogen balance

Additional relevant MeSH terms:
Inflammatory Bowel Diseases
Intestinal Diseases
Digestive System Diseases
Gastrointestinal Diseases
Anti-Inflammatory Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on February 11, 2016