Enteral Nutrition in Liver Cirrhosis

This study has been completed.
Sponsor:
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00168961
First received: September 13, 2005
Last updated: May 6, 2010
Last verified: September 2005
  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: 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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Liver cirrhosis (Child B or Child C)

Exclusion Criteria:

  • Malignant comorbidity
  • Encephalopathy
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00168961     History of Changes
Other Study ID Numbers: EE1
Study First Received: September 13, 2005
Last Updated: May 6, 2010
Health Authority: Germany: Ethics Commission

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

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

ClinicalTrials.gov processed this record on August 28, 2014