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

Completed

• Conditions: Inflammatory Bowel Diseases

• Registration Number: NCT00955123
• Lead Sponsor: University of Aarhus

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-08-03
• Study First Submitted QC: 2009-08-05
• Study First Posted: 2009-08-07
• Study Completion: 2011-12
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-11
• Last Update Posted: 2012-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Functional Hepatic Nitrogen Clearance	Before and one week after treatment

Secondary Outcome Measures

Name	Time	Method
Clinical and biochemical measures of inflammation	Before and one week after treatment

Trial Locations

Locations (1)

Department of Medicine V, Aarhus University Hospital; 🇩🇰 Aarhus, Denmark