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

Effects of Prednisolone and Infliximab on the Regulation of Urea Synthesis in Patients With Active Ulcerative Colitis and Crohn's Disease

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00955123

Enrollment

Registered

2009-08-07

Start date

2009-01-31

Completion date

2011-12-31

Last updated

2012-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory Bowel Diseases

Keywords

Inflammation, Urea synthesis, Catabolism, Nitrogen balance

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.

Interventions

None listed

Study design

Observational model

CASE_CROSSOVER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Functional Hepatic Nitrogen Clearance	Before and one week after treatment

Secondary

Measure	Time frame
Clinical and biochemical measures of inflammation	Before and one week after treatment

Countries

Denmark

Outcome results