None listed
Conditions
Brief summary
Liver transplantation is the only effective treatment for patients with advanced liver disease. This is a major operation which is associated with a high rate of complications over the early postoperative period which prolongs stay in hospital and is a major cause of early death. These complications are predominantly bacterial infections. A combination of prebiotics and probiotics (synbiotics) provided for one day before and 14 days after transplant has been shown to almost eliminate bacterial infections. This remarkable result requires confirmation for this treatment to be accepted into routine clinical practice. We propose to conduct a similar study using the same synbiotic. If this simple and inexpensive treatment reduces infections after transplant we expect it to lead to routine use in our liver transplant unit and adoption by other centres worldwide. This result and the associated reductions in antibiotic use and length of hospital stay are significant both for patients undergoing this life-saving procedure and for the hospital, given the consequential cost savings. We will also examine potential mechanisms that might explain the purported benefits of this treatment.
Interventions
A daily dose of Synbiotic 2000 Forte or placebo will be given as soon as possible after surgery and continuing for 14 days. Each dose (powder-containing sachet) of Synbiotic 2000 Forte contains 100 billion of each of Pediococcus pentosaceus 5-33:3, Leuconostoc mesenteroides 77:1, Lactobacillus paracasei ssp. Paracasei F19 and Lactobacillus plantarum 2362 plus four bioactive fibres (2.5 g each of beta-glucan, inulin, pectin and resistant starch). Compliance with treatment will be assessed for in-
A daily dose of Synbiotic 2000 Forte or placebo will be given as soon as possible after surgery and continuing for 14 days. Each dose (powder-containing sachet) of Synbiotic 2000 Forte contains 100 billion of each of Pediococcus pentosaceus 5-33:3, Leuconostoc mesenteroides 77:1, Lactobacillus paracasei ssp. Paracasei F19 and Lactobacillus plantarum 2362 plus four bioactive fibres (2.5 g each of beta-glucan, inulin, pectin and resistant starch). Compliance with treatment will be assessed for in-hospital patients by way of daily monitoring and after discharge using returned packaging.
Sponsors
Dr Lindsay Plank
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Listed for elective liver transplantation by the NZ Liver Transplant Unit (NZLTU); written informed consent.
Exclusion criteria
Acute liver failure.
Outcome results
None listed