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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00955123
Recruitment Status : Completed
First Posted : August 7, 2009
Last Update Posted : October 12, 2012
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease
Inflammatory Bowel Diseases

Study Design

Study Type : Observational
Actual Enrollment : 40 participants
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
Study Start Date : January 2009
Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
U.S. FDA Resources

Groups and Cohorts

Active inflammatory bowel disease
Patients with moderate to severe active inflammatory bowel disease (ulcerative colitis and Crohn's disease)

Outcome Measures

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

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

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

Eligibility Criteria

Information from the National Library of Medicine

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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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
ClinicalTrials.gov Identifier: NCT00955123     History of Changes
Other Study ID Numbers: FHNC-KLT
First Posted: August 7, 2009    Key Record Dates
Last Update Posted: October 12, 2012
Last Verified: October 2012

Keywords provided by Karen Louise Thomsen, 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