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

The effects of supplementation with synbiotics, branched chain amino acids on levels of hepatic encephalopathy in patients with cirrhosis

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610001021066

Enrollment

Registered

2010-11-22

Start date

2010-03-30

Completion date

2014-06-02

Last updated

2021-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study investigates the effects of branched chain amino acids and/or Synbiotics, a mixture of probiotics and prebiotics, on the level of hepatic encephalopthy in patients with cirrhosis using using computerised psychometric test and trail making test It also investigates the effects of branched chain amino acids and/or Synbiotics, a mixture of probiotics and prebiotics, on inflammatory process, quality of life, frequency and duration of hospitalisation, food intake and body composition.

Interventions

1. Synbiotics + branched chain amino acids (BCAAs) 2. BCAAs + Placebo for Synbiotics 3. Placebo for BCAAs + Placebo for Synbiotics 1. Synbiotic 2000 Forte is packaged in 10g single dose sachets which contain: Natural and digestible fibres: * 2.5g oat bran; * 2.5g pectin; * 2.5g resistant starch; * 2.5g inulin. Probiotic bacteria: * Lactobacillus paracasei ssp paracasei 10 x 10¹¹; * Lactobacillus plantarum 10 x 10¹¹; * Leuconostoc mesenteroides 10 x 10¹¹; * Pediococcus pentosaceus10 x 10¹¹ (Medipharm). Dose is 1 sachet/day mixed with juice, jam or honey according to patient's tolerance. Duration of supplementation is 56 days. 2. Branched Chain Amino Acid preparation - Hepatamine (Nutricia) which is a mixture of branched chain amino acids + sugars. Dose is 1 sachet at night mixed with 200ml lemonade, fruit juice. Duration of supplementation is 56 days."

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Healthy volunteers

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

Outcome results