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Trial registered on ANZCTR


Registration number
ACTRN12613001002774
Ethics application status
Approved
Date submitted
5/09/2013
Date registered
10/09/2013
Date last updated
10/09/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Gut bacteria targeted therapy for metabolic syndrome Post-Liver Transplant
Scientific title
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
Secondary ID [1] 283139 0
Nil
Universal Trial Number (UTN)
nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metabolic syndrome post liver transplant 289993 0
Condition category
Condition code
Diet and Nutrition 290375 290375 0 0
Obesity
Metabolic and Endocrine 290376 290376 0 0
Diabetes
Metabolic and Endocrine 290377 290377 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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..
Intervention code [1] 287867 0
Treatment: Other
Comparator / control treatment
VegeCaps
Control group
Placebo

Outcomes
Primary outcome [1] 290404 0
Sustained weight loss of >7% initial body weight on calibrated digital scales.
Timepoint [1] 290404 0
Week 16
Secondary outcome [1] 304430 0
Reduced liver fat as ascetained by fibroscan CAP
Timepoint [1] 304430 0
16 weeks
Secondary outcome [2] 304431 0
Reduced insulin resistance (HOMA-IR)
Timepoint [2] 304431 0
Week 16
Secondary outcome [3] 304432 0
Reduced ALT on serum assay
Timepoint [3] 304432 0
16 Weeks
Secondary outcome [4] 304433 0
Reduced cholesterol on serum assay
Timepoint [4] 304433 0
Week 16

Eligibility
Key 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
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients reviewed in the transplant clinic who fulfill inclusion criteria will be provided with information and the patient brochure outlining the trial.
If patient agrees to partake, then randomised via central computer generated number.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated randomisation numbers for 1:1 randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Power calculation, anticipate the primary endpoint will be achieved by 50% of those receiving the probiotic supplement and 5% of the placebo group, we will have 80% power to detect this difference at 5% level of significance with 18 cases and 18 controls (10% drop out, 20 patients in each arm).
Intention to treat analysis. Quantitative data, analysis performed using the Mann-Whitney and Kruskal-Wallis tests for comparisons of two or more than two independent groups. Difference in proportions of categorical data using Fisher’s exact test when the number of subjects is <5, and by Chi-square test for 2x2 tables when the number of subjects in each cell is =5. Multivariate logistic regression analysis to analyze clinical variables and treatment outcome. Continuous data categorized into normal and abnormal values for multivariate analysis, and by Youden index for cut-off variable of significance. Data will be expressed as means or median, range and interquartile range when appropriate. P values <0.05 is considered significant.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
23/09/2013
Actual
Date of last participant enrolment
Anticipated
6/03/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 5384 0
New Zealand
State/province [1] 5384 0

Funding & Sponsors
Funding source category [1] 287891 0
Charities/Societies/Foundations
Name [1] 287891 0
New Zealand Society of Gastroenterology (NZSG)
Country [1] 287891 0
New Zealand
Funding source category [2] 287892 0
Hospital
Name [2] 287892 0
Auckland Medical Research Fund
Country [2] 287892 0
New Zealand
Primary sponsor type
Individual
Name
David Orr
Address
New Zealand Liver Transplant Unit (NZLTU), level 15
Support Building
Auckland Hospital
Park Road, Grafton
Auckland
1148
Country
New Zealand
Secondary sponsor category [1] 286619 0
None
Name [1] 286619 0
Address [1] 286619 0
Country [1] 286619 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289833 0
Northern A Health and Disability Ethics Committee
Ethics committee address [1] 289833 0
Ministry of Health
1 the Terrace
PO Box 5013
Wellington
6011
Ethics committee country [1] 289833 0
New Zealand
Date submitted for ethics approval [1] 289833 0
07/02/2013
Approval date [1] 289833 0
13/05/2013
Ethics approval number [1] 289833 0
12/NTA/93

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 42650 0
Dr David Orr
Address 42650 0
Level 15, Support building
NZLTU
Park Road
Grafton
Auckland Hospital
1148
Country 42650 0
New Zealand
Phone 42650 0
+6493074949
Fax 42650 0
Email 42650 0
[email protected]
Contact person for public queries
Name 42651 0
David Orr
Address 42651 0
Level 15, Support building
NZLTU
Park Road
Grafton
Auckland Hospital
1148
Country 42651 0
New Zealand
Phone 42651 0
+6493074949
Fax 42651 0
Email 42651 0
[email protected]
Contact person for scientific queries
Name 42652 0
David Orr
Address 42652 0
Level 15, Support building
NZLTU
Park Road
Grafton
Auckland Hospital
1148
Country 42652 0
New Zealand
Phone 42652 0
+6493074949
Fax 42652 0
Email 42652 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseRandomised double-blind placebo-controlled trial of inulin with metronidazole in non-alcoholic fatty liver disease (NAFLD).2020https://dx.doi.org/10.3390/nu12040937
N.B. These documents automatically identified may not have been verified by the study sponsor.