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Short Term Feeding for Asian Patients With Liver Cirrhosis

Primary Purpose

CIRRHOSIS

Status
Completed
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Osmolite and B.C.A.A.
Normal oral intake & supplementation if necessary
Sponsored by
University of Malaya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for CIRRHOSIS focused on measuring Cirrhosis, Malnutrition, Enteral nutrition

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with decompensated cirrhosis of any etiology.

Exclusion Criteria:

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

Sites / Locations

  • University of Malaya Medical Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Naso-gastric tube feeding

Oral feeding

Arm Description

Outcomes

Primary Outcome Measures

Improvement in Child-Pugh score
Change in the Child-Pugh score, assessing liver damage in cirrhosis

Secondary Outcome Measures

Improvement in nutritional parameters
Improvement in nutritional anthropometry and assessment tool markers after intervention

Full Information

First Posted
July 16, 2010
Last Updated
February 27, 2011
Sponsor
University of Malaya
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1. Study Identification

Unique Protocol Identification Number
NCT01165073
Brief Title
Short Term Feeding for Asian Patients With Liver Cirrhosis
Official Title
Short Term Feeding for Hospitalised Asian Patients With Liver Cirrhosis - a Randomised Trial of Naso-gastric vs Oral Feeding
Study Type
Interventional

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Malaya

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
CIRRHOSIS
Keywords
Cirrhosis, Malnutrition, Enteral nutrition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Naso-gastric tube feeding
Arm Type
Experimental
Arm Title
Oral feeding
Arm Type
Active Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Osmolite and B.C.A.A.
Other Intervention Name(s)
Enteral supplementation
Intervention Description
Feeding inserted into enteral tubes
Intervention Type
Dietary Supplement
Intervention Name(s)
Normal oral intake & supplementation if necessary
Other Intervention Name(s)
Enteral supplementation
Intervention Description
Enteral nutrition
Primary Outcome Measure Information:
Title
Improvement in Child-Pugh score
Description
Change in the Child-Pugh score, assessing liver damage in cirrhosis
Time Frame
Up to 6 weeks
Secondary Outcome Measure Information:
Title
Improvement in nutritional parameters
Description
Improvement in nutritional anthropometry and assessment tool markers after intervention
Time Frame
up to 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with decompensated cirrhosis of any etiology. Exclusion Criteria: Advanced hepatic encephalopathy, Variceal bleeding, Hepatocellular carcinoma.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sanjiv Mahadeva, MRCP
Organizational Affiliation
University of Malaya
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mei-Ling S Tai, MRCP
Organizational Affiliation
University of Malaya
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Malaya Medical Centre
City
Kuala Lumpur
State/Province
Federal Territory
ZIP/Postal Code
59100
Country
Malaysia

12. IPD Sharing Statement

Citations:
PubMed Identifier
2105256
Citation
Cabre E, Gonzalez-Huix F, Abad-Lacruz A, Esteve M, Acero D, Fernandez-Banares F, Xiol X, Gassull MA. Effect of total enteral nutrition on the short-term outcome of severely malnourished cirrhotics. A randomized controlled trial. Gastroenterology. 1990 Mar;98(3):715-20. doi: 10.1016/0016-5085(90)90293-a.
Results Reference
result
PubMed Identifier
16141996
Citation
Campillo B, Richardet JP, Bories PN. Enteral nutrition in severely malnourished and anorectic cirrhotic patients in clinical practice. Gastroenterol Clin Biol. 2005 Jun-Jul;29(6-7):645-51. doi: 10.1016/s0399-8320(05)82150-5.
Results Reference
result
PubMed Identifier
12781851
Citation
Campillo B, Richardet JP, Scherman E, Bories PN. Evaluation of nutritional practice in hospitalized cirrhotic patients: results of a prospective study. Nutrition. 2003 Jun;19(6):515-21. doi: 10.1016/s0899-9007(02)01071-7.
Results Reference
result
PubMed Identifier
9252101
Citation
Kondrup J, Muller MJ. Energy and protein requirements of patients with chronic liver disease. J Hepatol. 1997 Jul;27(1):239-47. doi: 10.1016/s0168-8278(97)80308-x. No abstract available.
Results Reference
result
PubMed Identifier
16844569
Citation
Plauth M, Merli M, Kondrup J, Weimann A, Ferenci P, Muller MJ; ESPEN Consensus Group. ESPEN guidelines for nutrition in liver disease and transplantation. Clin Nutr. 1997 Apr;16(2):43-55. doi: 10.1016/s0261-5614(97)80022-2. No abstract available.
Results Reference
result
PubMed Identifier
15723736
Citation
Alvares-da-Silva MR, Reverbel da Silveira T. Comparison between handgrip strength, subjective global assessment, and prognostic nutritional index in assessing malnutrition and predicting clinical outcome in cirrhotic outpatients. Nutrition. 2005 Feb;21(2):113-7. doi: 10.1016/j.nut.2004.02.002.
Results Reference
result

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Short Term Feeding for Asian Patients With Liver Cirrhosis

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