Gut bacteria targeted therapy for metabolic syndrome Post-Liver Transplant

INTERVENTION: Randomisation of 40 post liver transplant patients from the Auckland Liver Transplant Unit to one of 2 study groups in a double‐blind, placebo controlled study. Both groups will receive 4 weeks of VLCD (Optifast). This consists of 3 Optifast drinks per day and 2 cups of vegetables per day, with 2 teaspoons of vegetable oil (800 cal/day). After the Optifast phase patients will commence a healthy diet as advised by the study team and healthy eating booklet. Dietary advice will be given every 4 weeks with face to face interview during the treatment phase. These sessions will be conducted by the gastroenterologist and/or research nurse during study visits which will take up to 1 hour. Patients will be randomised to 12 weeks of probiotic Lactobacillus rhamnosus and Bifidobacterium animalis (14B CFU), (1 capsule orally twice daily), or identical appearing placebo in the control group (1 capsule orally twice daily) prior to lunch and dinner. Patients will return with their left over tablets at the conclusion of the trial to assess compliance and will be asked regarding compliance and any adverse effects at each clinical assessment every 4 weeks.. CONDITION: Metabolic syndrome post liver transplant PRIMARY OUTCOME: Sustained weight loss of >7% initial body weight on calibrated digital scales. SECONDARY OUTCOME: Reduced ALT on serum assay Reduced cholesterol on serum assay Reduced insulin resistance (HOMA‐IR) Reduced liver fat as ascetained by fibroscan CAP INCLUSION CRITERIA: Post Liver transplant (>6‐months post transplant) Glucose intolerance or type II diabetes (or liver biopsy proven NAFLD) Age 18‐75. BMI >27kg/m2