The Effects of Synbiotics, Branched Chain Amino Acids on Hepatic Encephalopathy

Not Applicable

Completed

• Conditions: Hepatic encephalopathy in patients with cirrhosis; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon; Diet and Nutrition - Other diet and nutrition disorders

• Registration Number: ACTRN12610001021066
• Lead Sponsor: Royal Prince Alfred Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-11-22
• Last Update Posted: 16 February 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Childs B or C cirrhosis on lactulose aged between 18 - 70 yrs who are abstinent from alcohol and illegal drugs for at least six months. If on methadone must be dose stable for >6 months

Exclusion Criteria

pregnancy
< 18yrs
> 70yrs
current alcohol use
current iv drug use
sepsis
grade 4 encephalopathy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Effects of supplementation with Synbiotics and/or branched chain amino acids (BCAAs) on levels of hepatic encephalopathy<br>This is assessed using the Trail Making Tests A and B and the Inhibitory Control Test.<br>In addition, biochemical markers for liver function and inflammatory processes as well as changes in quality of life and nutritional responses to interventions will also be collated (CTP, MELD, TNF, IL-6, MAC, TSF, MAMC, food intakes, hospitalisations, depression and anxiety scores and LDSFQOL[Timepoints at baseline, one month and 2 months after randomisation]