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Short Term Feeding for Asian Patients With Liver Cirrhosis

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ClinicalTrials.gov Identifier: NCT01165073
Recruitment Status : Completed
First Posted : July 19, 2010
Last Update Posted : March 1, 2011
Sponsor:
Information provided by:
University of Malaya

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 Phase
CIRRHOSIS Dietary Supplement: Osmolite and B.C.A.A. Dietary Supplement: Normal oral intake & supplementation if necessary Not Applicable

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 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
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis

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




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



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

Inclusion Criteria:

  • Patients with decompensated cirrhosis of any etiology.

Exclusion Criteria:

  • Advanced hepatic encephalopathy,
  • Variceal bleeding,
  • Hepatocellular carcinoma.

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


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

Publications of Results:
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:
Cirrhosis
Malnutrition
Enteral nutrition

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