Enteral Nutrition in Liver Cirrhosis

This study is currently recruiting participants.

Verified by Charite University, Berlin, Germany, September 2005

Sponsored by:	Charite University, Berlin, Germany
Information provided by:	Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:	NCT00168961

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 IV

MedlinePlus related topics: Cirrhosis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Open Label, Placebo Control, Parallel Assignment

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

Study Start Date:

December 2003

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00168961

Contacts

Contact: Ute Friedrich, MD

030 450 514039

uetfriedrich@web.de

Locations

Germany
Charite Universitätsmedizin Klinik für Gastroenterologie	Recruiting
Berlin, Germany, 10117
Contact: Matthias Pirlich, MD +49 30 450 514 ext 062 matthias.pirlich@charite.de

Sponsors and Collaborators

Charite University, Berlin, Germany

Investigators

Principal Investigator:

Matthias Pirlich, MD

Charite Universitätsmedizin CCM Klinik für Gastroenterologie

More Information

Study ID Numbers:	EE1
Study First Received:	September 13, 2005
Last Updated:	August 27, 2007
ClinicalTrials.gov Identifier:	NCT00168961
Health Authority:	Germany: Ethics Commission

Keywords provided by Charite University, Berlin, Germany:

liver cirrhosis Child B or C

Study placed in the following topic categories:

Liver Diseases
Digestive System Diseases
Fibrosis
Liver Cirrhosis

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 13, 2009