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Short Term Feeding for Asian Patients With 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.
ClinicalTrials.gov Identifier: NCT01165073
Recruitment Status : Completed
First Posted : July 19, 2010
Last Update Posted : March 1, 2011
Information provided by:

Study Description
Brief Summary:
The benefits of short-term naso-gastric feeding in patients with advanced cirrhosis remain uncertain. This was a randomised study comparing naso-gastric feeding and oral feeding in Asian patients with cirrhosis who were admitted to hospital for decompensation.

Condition or disease Intervention/treatment
CIRRHOSIS Dietary Supplement: Osmolite and B.C.A.A. Dietary Supplement: Normal oral intake & supplementation if necessary

Detailed Description:
Consecutive patients with decompensated cirrhosis who fitted the inclusion criteria, will be randomised to either naso-gastric or oral feeding. Total feeding will be for 2 weeks only. Following intervention specific nutritional and liver-related parameters will be measured during the 2 weeks and up to 6 weeks later. Comparison between both groups will then be made.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Short Term Feeding for Hospitalised Asian Patients With Liver Cirrhosis - a Randomised Trial of Naso-gastric vs Oral Feeding
Study Start Date : March 2008
Primary Completion Date : May 2009
Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Naso-gastric tube feeding Dietary Supplement: Osmolite and B.C.A.A.
Feeding inserted into enteral tubes
Other Name: Enteral supplementation
Active Comparator: Oral feeding Dietary Supplement: Normal oral intake & supplementation if necessary
Enteral nutrition
Other Name: Enteral supplementation

Outcome Measures

Primary Outcome Measures :
  1. Improvement in Child-Pugh score [ Time Frame: Up to 6 weeks ]
    Change in the Child-Pugh score, assessing liver damage in cirrhosis

Secondary Outcome Measures :
  1. Improvement in nutritional parameters [ Time Frame: up to 6 weeks ]
    Improvement in nutritional anthropometry and assessment tool markers after intervention

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with decompensated cirrhosis of any etiology.

Exclusion Criteria:

  • Advanced hepatic encephalopathy,
  • Variceal bleeding,
  • Hepatocellular carcinoma.
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT01165073

University of Malaya Medical Centre
Kuala Lumpur, Federal Territory, Malaysia, 59100
Sponsors and Collaborators
University of Malaya
Study Director: Sanjiv Mahadeva, MRCP University of Malaya
Principal Investigator: Mei-Ling S Tai, MRCP University of Malaya
More Information

Responsible Party: Dr Sanjiv Mahadeva/ Dr Sharon Tai Mei Ling, University of Malaya
ClinicalTrials.gov Identifier: NCT01165073     History of Changes
Other Study ID Numbers: NGVOC1
First Posted: July 19, 2010    Key Record Dates
Last Update Posted: March 1, 2011
Last Verified: July 2010

Keywords provided by University of Malaya:
Enteral nutrition

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