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Enteral Nutrition in Liver Cirrhosis

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. Identifier: NCT00168961
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : May 7, 2010
Information provided by:
Charite University, Berlin, Germany

Brief Summary:

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 or disease Intervention/treatment Phase
Liver Cirrhosis Dietary Supplement: High Protein Energy, Fresenius-Kabi (nutritional intervention) Phase 4

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Study Start Date : December 2003
Actual Primary Completion Date : December 2006
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Liver cirrhosis (Child B or Child C)

Exclusion Criteria:

  • Malignant comorbidity
  • Encephalopathy

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 identifier (NCT number): NCT00168961

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Charite Universitätsmedizin Klinik für Gastroenterologie
Berlin, Germany, 10117
Sponsors and Collaborators
Charite University, Berlin, Germany
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Principal Investigator: Matthias Pirlich, MD Charite Universitätsmedizin CCM Klinik für Gastroenterologie
Layout table for additonal information Identifier: NCT00168961    
Other Study ID Numbers: EE1
First Posted: September 15, 2005    Key Record Dates
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:
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Liver Cirrhosis
Pathologic Processes
Liver Diseases
Digestive System Diseases