CIRRHOSISNCT01165073
Short Term Feeding for Asian Patients With Liver Cirrhosis
A study testing Osmolite and B.C.A.A. and Normal oral intake & supplementation if necessary in people with CIRRHOSIS, run by University of Malaya at 1 site in Malaysia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CIRRHOSIS
- What is being tested?
- Osmolite and B.C.A.A. and Normal oral intake & supplementation if necessary
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteMalaysia
- Study dates
- Mar 2008to May 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with decompensated cirrhosis of any etiology.
Who cannot join
- Advanced hepatic encephalopathy,
- Variceal bleeding,
- Hepatocellular carcinoma.
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
University of Malaya Medical Centre
Kuala Lumpur, Kuala Lumpur, 59100
About this study
Official title: Short Term Feeding for Hospitalised Asian Patients With Liver Cirrhosis - a Randomised Trial of Naso-gastric vs Oral Feeding
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.
Read the 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.
- Conditions
- CIRRHOSIS
- Being tested
- Osmolite and B.C.A.A., Normal oral intake & supplementation if necessary
- Keywords
- Cirrhosis, Malnutrition, Enteral nutrition
- Medical subject headings
- Fibrosis, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osmolite and B.C.A.A.Dietary supplement
Also called Enteral supplementation
Feeding inserted into enteral tubes
Normal oral intake & supplementation if necessaryDietary supplement
Also called Enteral supplementation
Enteral nutrition
| Study group | Role | What they receive |
|---|---|---|
| Naso-gastric tube feeding | Experimental | Not described Receives: Dietary Supplement: Osmolite and B.C.A.A. |
| Oral feeding | Active comparator | Not described Receives: Dietary Supplement: Normal oral intake & supplementation if necessary |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Child-Pugh score
Change in the Child-Pugh score, assessing liver damage in cirrhosis
Measured: Up to 6 weeks
Secondary outcomes (1)
Improvement in nutritional parameters
Improvement in nutritional anthropometry and assessment tool markers after intervention
Measured: up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2010 (estimated)
- Study startMar 2008
- Primary completionMay 2009
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for CIRRHOSISStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Investigators
- Sanjiv Mahadeva, MRCP, Study director, University of MalayaMei-Ling S Tai, MRCP, Principal investigator, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01165073
- Sponsor's protocol ID
- NGVOC1
- Status last verified
- Jul 2010
- First submitted
- 16 Jul 2010
- Last updated
- 1 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 2105256Campillo 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.
PubMed 16141996Campillo 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.
PubMed 12781851Kondrup 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.
PubMed 9252101Plauth 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.
PubMed 16844569Alvares-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.
PubMed 15723736
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Term Feeding for Hospitalised Asian Patients With Liver Cirrhosis - a Randomised Trial of Naso-gastric vs Oral Feeding
- ClinicalTrials.gov ID
- NCT01165073
- Acronym / sponsor ID
- NGVOC1
- Conditions
- CIRRHOSIS
- Keywords
- Cirrhosis, Malnutrition, Enteral nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- May 2009 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 19 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with decompensated cirrhosis of any etiology.
Key exclusion criteria (3 listed)
- Advanced hepatic encephalopathy,
- Variceal bleeding,
- Hepatocellular carcinoma.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Osmolite and B.C.A.A.Also: Enteral supplementationFeeding inserted into enteral tubes | Dietary supplement | Naso-gastric tube feeding |
| Normal oral intake & supplementation if necessaryAlso: Enteral supplementationEnteral nutrition | Dietary supplement | Oral feeding |
Primary outcome
Improvement in Child-Pugh score
Time frame: Up to 6 weeks
Change in the Child-Pugh score, assessing liver damage in cirrhosis
1 secondary outcome
Improvement in nutritional parameters
Time frame: up to 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2011.
- Results publication: PubMed 2105256Cabre 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.
- Results publication: PubMed 16141996Campillo 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.
- Results publication: PubMed 12781851Campillo 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.
- Results publication: PubMed 9252101Kondrup 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.
- Results publication: PubMed 16844569Plauth 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.
- Results publication: PubMed 15723736Alvares-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sanjiv Mahadeva, MRCP study director
University of Malaya
Mei-Ling S Tai, MRCP principal investigator
University of Malaya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osmolite and B.C.A.A. and Normal oral intake & supplementation if necessary in people with CIRRHOSIS, run by University of Malaya at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in Child-Pugh score (time frame: Up to 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01165073, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2011.