None listed
Conditions
Brief summary
The risk factors of obesity, diabetes and elevated cholesterol increase the risk of heart disease after liver transplant. There is recent animal evidence that the gut organisms play an important part in the risk of having these problems. This research project is designed to see if probiotics prevent weight gain after a low calorie diet for 4 weeks and improve blood sugar control and cholesterol, and reduce fat within the liver in patients who have previously undergone liver transplant.
Interventions
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..
Sponsors
Study design
Eligibility
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
Exclusion criteria
alcohol consumption>20g/d, decompensated liver disease, chronic gastrointestinal disease, pregnancy, severe medical conditions, allergy to eggs/nuts, medications known to cause steatohepatitis. renal dysfunction eGFR <40ml/min