Enteral Nutrition in Liver Cirrhosis

NCT ID: NCT00168961

Last Updated: 2010-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2003-12-31

Study Completion Date

2007-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Liver Cirrhosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Interventions

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High Protein Energy, Fresenius-Kabi (nutritional intervention)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Liver cirrhosis (Child B or Child C)

Exclusion Criteria

* Malignant comorbidity
* Encephalopathy
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Principal Investigators

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Matthias Pirlich, MD

Role: PRINCIPAL_INVESTIGATOR

Charite Universitätsmedizin CCM Klinik für Gastroenterologie

Locations

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Charite Universitätsmedizin Klinik für Gastroenterologie

Berlin, , Germany

Site Status

Countries

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Germany

Other Identifiers

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EE1

Identifier Type: -

Identifier Source: org_study_id

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