NCT01165073

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 16, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 19, 2010

Completed
Last Updated

March 1, 2011

Status Verified

July 1, 2010

Enrollment Period

1.2 years

First QC Date

July 16, 2010

Last Update Submit

February 27, 2011

Conditions

CIRRHOSIS

Keywords

CirrhosisMalnutritionEnteral nutrition

Outcome Measures

Primary Outcomes (1)

  • Improvement in Child-Pugh score

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

    Up to 6 weeks

Secondary Outcomes (1)

  • Improvement in nutritional parameters

    up to 6 weeks

Study Arms (2)

Naso-gastric tube feeding

EXPERIMENTAL
Dietary Supplement: Osmolite and B.C.A.A.

Oral feeding

ACTIVE COMPARATOR
Dietary Supplement: Normal oral intake & supplementation if necessary

Interventions

Osmolite and B.C.A.A.DIETARY_SUPPLEMENT

Feeding inserted into enteral tubes

Also known as: Enteral supplementation
Naso-gastric tube feeding
Normal oral intake & supplementation if necessaryDIETARY_SUPPLEMENT

Enteral nutrition

Also known as: Enteral supplementation
Oral feeding

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with decompensated cirrhosis of any etiology.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Malaya Medical Centre

Kuala Lumpur, Kuala Lumpur, 59100, Malaysia

Location

Related Publications (6)

  • 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.

    PMID: 2105256RESULT

  • 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.

    PMID: 16141996RESULT

  • 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.

    PMID: 12781851RESULT

  • 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.

    PMID: 9252101RESULT

  • 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.

    PMID: 16844569RESULT

  • 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.

    PMID: 15723736RESULT

MeSH Terms

Conditions

FibrosisMalnutrition

Interventions

Osmolite

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Sanjiv Mahadeva, MRCP

    University of Malaya

    STUDY DIRECTOR

  • Mei-Ling S Tai, MRCP

    University of Malaya

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 16, 2010

First Posted

July 19, 2010

Study Start

March 1, 2008

Primary Completion

May 1, 2009

Study Completion

May 1, 2010

Last Updated

March 1, 2011

Record last verified: 2010-07

Locations

MY(1)