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

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.

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Key information

Conditions

Inflammatory Bowel Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammation Intestinal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Medicine V, Aarhus University Hospital

Aarhus, 8000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Functional Hepatic Nitrogen Clearance

Time frame: Before and one week after treatment

Secondary outcomes

Clinical and biochemical measures of inflammation

Time frame: Before and one week after treatment

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

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

Important dates

Study start: 2009
Study completion: 2011
First posted: Aug 7, 2009
Registry last updated: Oct 12, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed