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NCT00168961 Clinical Trial

Enteral Nutrition in Liver Cirrhosis

Liver Cirrhosis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00168961
Other study ID # EE1
Secondary ID
Status Completed
Phase Phase 4
First received September 13, 2005
Last updated May 6, 2010
Start date December 2003
Est. completion date June 2007

Study information
Verified date September 2005
Source Charite University, Berlin, Germany
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date June 2007
Est. primary completion date December 2006
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria:

- Liver cirrhosis (Child B or Child C)

Exclusion Criteria:

- Malignant comorbidity

- Encephalopathy

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• High Protein Energy, Fresenius-Kabi (nutritional intervention)

Locations
Country Name City State
Germany Charite Universitätsmedizin Klinik für Gastroenterologie Berlin

Sponsors (1)
Lead Sponsor Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

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