Short Term Feeding for Asian Patients With Liver Cirrhosis

NCT ID: NCT01165073

Last Updated: 2011-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2010-05-31

Brief Summary

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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

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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.

Conditions

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CIRRHOSIS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Naso-gastric tube feeding

Group Type EXPERIMENTAL

Osmolite and B.C.A.A.

Intervention Type DIETARY_SUPPLEMENT

Feeding inserted into enteral tubes

Oral feeding

Group Type ACTIVE_COMPARATOR

Normal oral intake & supplementation if necessary

Intervention Type DIETARY_SUPPLEMENT

Enteral nutrition

Interventions

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Osmolite and B.C.A.A.

Feeding inserted into enteral tubes

Intervention Type DIETARY_SUPPLEMENT

Normal oral intake & supplementation if necessary

Enteral nutrition

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Enteral supplementation Enteral supplementation

Eligibility Criteria

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Inclusion Criteria

* Patients with decompensated cirrhosis of any etiology.

Exclusion Criteria

* Advanced hepatic encephalopathy,
* Variceal bleeding,
* Hepatocellular carcinoma.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Malaya

OTHER

Sponsor Role lead

Responsible Party

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University of Malaya

Principal Investigators

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Sanjiv Mahadeva, MRCP

Role: STUDY_DIRECTOR

University of Malaya

Mei-Ling S Tai, MRCP

Role: PRINCIPAL_INVESTIGATOR

University of Malaya

Locations

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University of Malaya Medical Centre

Kuala Lumpur, Kuala Lumpur, Malaysia

Site Status

Countries

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Malaysia

References

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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.

Reference Type RESULT
PMID: 2105256 (View on PubMed)

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.

Reference Type RESULT
PMID: 16141996 (View on PubMed)

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.

Reference Type RESULT
PMID: 12781851 (View on PubMed)

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.

Reference Type RESULT
PMID: 9252101 (View on PubMed)

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.

Reference Type RESULT
PMID: 16844569 (View on PubMed)

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.

Reference Type RESULT
PMID: 15723736 (View on PubMed)

Other Identifiers

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NGVOC1

Identifier Type: -

Identifier Source: org_study_id

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