Short Term Feeding for Asian Patients With Liver Cirrhosis | NCT01165073

Studies
Short Term Feeding for Asian Patients With Liver Cirrhosis

NCT01165073

Sponsor

University of Malaya

Status

Completed

Last Update Posted

Mar 1, 2011Estimated

Enrollment

52Actual

Phase

Not Applicable

Conditions

CIRRHOSIS

Interventions

Osmolite and B.C.A.A.
Normal oral intake & supplementation if necessary

Countries

Malaysia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2008

Primary Completion Date

May 2009Actual

Completion Date

May 2010Actual

First Submitted Date

Jul 16, 2010

First Submission Date that Met QC Criteria

Jul 16, 2010

First Posted Date

Jul 19, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 27, 2011

Last Update Posted Date

Mar 1, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

52Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Osmolite and B.C.A.A.	Dietary Supplement	Feeding inserted into enteral tubes	Naso-gastric tube feeding

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Improvement in Child-Pugh score	Change in the Child-Pugh score, assessing liver damage in cirrhosis	Up to 6 weeks

Secondary Outcomes

Measure	Description	Time Frame
Improvement in nutritional parameters	Improvement in nutritional anthropometry and assessment tool markers after intervention	up to 6 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with decompensated cirrhosis of any etiology.

Exclusion Criteria:

Advanced hepatic encephalopathy,
Variceal bleeding,
Hepatocellular carcinoma.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sanjiv Mahadeva, MRCP	University of Malaya	Study Director
Mei-Ling S Tai, MRCP	University of Malaya	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Malaya Medical Centre		Kuala Lumpur	Kuala Lumpur	59100	Malaysia

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
2105256	Result	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.
16141996	Result

Type	Date	Date Unknown
Release	Aug 9, 2011
Reset	Sep 12, 2011
Release	Jun 28, 2013
Unrelease		Yes
Release	Nov 24, 2013
Reset	Jan 10, 2014
Release	May 6, 2014
Reset	May 31, 2014

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Aug 9, 2011			Sep 12, 2011
Jun 28, 2013

ID	Term
D005355	Fibrosis
D044342	Malnutrition

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases