Short Term Feeding for Asian Patients With Liver Cirrhosis - Full Text View

Purpose

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	Intervention
CIRRHOSIS	Dietary Supplement: Osmolite and B.C.A.A. Dietary Supplement: Normal oral intake & supplementation if necessary

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

Genetics Home Reference related topics: North American Indian childhood cirrhosis

MedlinePlus related topics: Cirrhosis

U.S. FDA Resources

Further study details as provided by University of Malaya:

Primary Outcome Measures:

Improvement in Child-Pugh score [ Time Frame: Up to 6 weeks ] [ Designated as safety issue: No ]
Change in the Child-Pugh score, assessing liver damage in cirrhosis

Secondary Outcome Measures:

Improvement in nutritional parameters [ Time Frame: up to 6 weeks ] [ Designated as safety issue: No ]
Improvement in nutritional anthropometry and assessment tool markers after intervention

Enrollment:	52
Study Start Date:	March 2008
Study Completion Date:	May 2010
Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with decompensated cirrhosis of any etiology.

Exclusion Criteria:

Advanced hepatic encephalopathy,
Variceal bleeding,
Hepatocellular carcinoma.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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

More Information

Publications:

Cabre E, Gonzalez-Huix F, Abad-Lacruz A, Esteve M, Acero D, Fernandez-Bañares 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.

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.

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.

Kondrup J, Müller MJ. Energy and protein requirements of patients with chronic liver disease. J Hepatol. 1997 Jul;27(1):239-47. Review. No abstract available.

Plauth M, Merli M, Kondrup J, Weimann A, Ferenci P, Müller MJ; ESPEN Consensus Group. ESPEN guidelines for nutrition in liver disease and transplantation. Clin Nutr. 1997 Apr;16(2):43-55. No abstract available.

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.

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
Study First Received:	July 16, 2010
Last Updated:	February 27, 2011
Health Authority:	Malaysia: Ministry of Health

Keywords provided by University of Malaya:

Cirrhosis
Malnutrition
Enteral nutrition

Additional relevant MeSH terms:

Liver Cirrhosis
Fibrosis
Liver Diseases
Digestive System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013