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Enteral Nutrition in Liver Cirrhosis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00168961
First Posted: September 15, 2005
Last Update Posted: May 7, 2010
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.
Information provided by:
Charite University, Berlin, Germany
  Purpose

Malnutrition is frequently occurring in patients with liver cirrhosis and is associated with a poorer outcome, as it determines life quality and affects both morbidity and mortality.

Long term prognosis after liver transplantation also depends on the nutritional status.

Therefore, the early diagnosis and intervention for malnutrition is an important issue in the clinical management of liver cirrhosis. However, oral intake has been shown to be insufficient due to disease related anorexia or concomitant drowsiness and confusion.

Specific aims: To investigate the effect of early nutritional intervention via tube feeding on nutritional status, functional status (hand grip strength and peak flow), life quality and disease related complications such as intestinal permeability, and oxidative stress, as well as liver function.


Condition Intervention Phase
Liver Cirrhosis Dietary Supplement: High Protein Energy, Fresenius-Kabi (nutritional intervention) Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Study Start Date: December 2003
Study Completion Date: June 2007
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Liver cirrhosis (Child B or Child C)

Exclusion Criteria:

  • Malignant comorbidity
  • Encephalopathy
  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): NCT00168961


Locations
Germany
Charite Universitätsmedizin Klinik für Gastroenterologie
Berlin, Germany, 10117
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Principal Investigator: Matthias Pirlich, MD Charite Universitätsmedizin CCM Klinik für Gastroenterologie
  More Information

ClinicalTrials.gov Identifier: NCT00168961     History of Changes
Other Study ID Numbers: EE1
First Submitted: September 13, 2005
First Posted: September 15, 2005
Last Update Posted: May 7, 2010
Last Verified: September 2005

Keywords provided by Charite University, Berlin, Germany:
liver cirrhosis Child B or C

Additional relevant MeSH terms:
Fibrosis
Liver Cirrhosis
Pathologic Processes
Liver Diseases
Digestive System Diseases