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Gut bacteria targeted therapy for metabolic syndrome Post-Liver Transplant

Randomised controlled trial to assess if Very low calorie diet (VLCD) followed by probiotic supplementation is superior to VLCD alone in achieving sustained improvement in weight loss and the metabolic syndrome post Liver Transplant

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12613001002774
Enrollment
40
Registered
2013-09-10
Start date
2013-09-23
Completion date
2014-03-06
Last updated
2020-01-13

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

Conditions

None listed

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 w

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

David Orr
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026