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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Karen Louise Thomsen, University of Aarhus
ClinicalTrials.gov Identifier:
NCT00955123
First received: August 3, 2009
Last updated: October 11, 2012
Last verified: October 2012
  Purpose

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

  Eligibility

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.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00955123

Locations
Denmark
Department of Medicine V, Aarhus University Hospital
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Investigators
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:
Inflammation
Urea synthesis
Catabolism
Nitrogen balance

Additional relevant MeSH terms:
Inflammatory Bowel Diseases
Intestinal Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Methylprednisolone acetate
Prednisolone acetate
Infliximab
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on July 20, 2014