Short Term Feeding for Asian Patients With Liver Cirrhosis

CIRRHOSIS Clinical Trial

Official title:

Short Term Feeding for Hospitalised Asian Patients With Liver Cirrhosis - a Randomised Trial of Naso-gastric vs Oral Feeding

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01165073
• Other study ID #: NGVOC1
• Status: Completed
• Phase: N/A
• First received: July 16, 2010
• Last updated: February 27, 2011
• Start date: March 2008
• Est. completion date: May 2010

Study information

• Verified date: July 2010
• Source: University of Malaya
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: May 2010
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with decompensated cirrhosis of any etiology.

Exclusion Criteria:

• Advanced hepatic encephalopathy,

• Variceal bleeding,

• Hepatocellular carcinoma.

Related Conditions & MeSH terms

• CIRRHOSIS
• Fibrosis
• Liver Cirrhosis

Intervention

Dietary Supplement:
• Osmolite and B.C.A.A.
Feeding inserted into enteral tubes
• Normal oral intake & supplementation if necessary
Enteral nutrition

Locations

Country	Name	City	State
Malaysia	University of Malaya Medical Centre	Kuala Lumpur	Federal Territory

Sponsors (1)

Lead Sponsor	Collaborator
University of Malaya

Country where clinical trial is conducted

Malaysia, 

References & Publications (6)

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) — View Citation

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 — View 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. — View 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. — View Citation

Kondrup J, Müller MJ. Energy and protein requirements of patients with chronic liver disease. J Hepatol. 1997 Jul;27(1):239-47. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in Child-Pugh score	Change in the Child-Pugh score, assessing liver damage in cirrhosis	Up to 6 weeks
Secondary	Improvement in nutritional parameters	Improvement in nutritional anthropometry and assessment tool markers after intervention	up to 6 weeks