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Trial registered on ANZCTR


Registration number
ACTRN12618001057279p
Ethics application status
Not yet submitted
Date submitted
19/06/2018
Date registered
25/06/2018
Date last updated
25/06/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility study of a randomised controlled trial of prebiotic supplementation in reducing infections and gastrointestinal upset in kidney transplant recipients
Scientific title
Feasibility study of a randomised controlled trial of prebiotic supplementation in reducing infections and gastrointestinal upset in kidney transplant recipients
Secondary ID [1] 295236 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Kidney disease 308412 0
Kidney transplant 308447 0
Condition category
Condition code
Renal and Urogenital 307402 307402 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be provided with a prebiotic supplement or placebo (powder sachet dissolved in water) for eight weeks duration. This will be administered orally as a powder sachet dissolved in water. The prebiotic will be Green Banana Resistant Starch. The prebiotic will be commenced at ½ dose for the first two weeks to enable gut adaption with the full dose given for six weeks. The starting dose will be 7.5mg twice daily (morning and evening) for the first two weeks, and then move to 15mg twice daily for six weeks (morning and evening). The strains and dosage have been selected based on previous studies demonstrating reduction in these target uremic toxins from single treatment. Patients will attend their kidney transplant outpatient clinic each week, and will have their blood tests taken prior to clinic each week. To monitor adherence of the intervention, powder sachet returns will be checked.
Intervention code [1] 301581 0
Treatment: Drugs
Comparator / control treatment
Placebo: Matched Powder: maltodextrin
Control group
Placebo

Outcomes
Primary outcome [1] 306374 0
The primary outcome will be adherence to the prebiotic (i.e. weight of the product returned on electronic kitchen scales from the dispensed weight)
Timepoint [1] 306374 0
Adherence to the Green Banana Resistant Starch will be assessed at the end of the study.
Patients will be seen clinically each week at the transplant clinic outpatients setting for a clinical review. The adherence parameter will be measured at the end of the study, i.e. at the eight week mark after kidney transplantation
Secondary outcome [1] 348281 0
Assessment of gastrointestinal microbiota by examining stool sample microbiology
Timepoint [1] 348281 0
Measured at two timepoints
a) the first time point is before the kidney transplant
b) the second time point is at the four week mark after kidney transplant
Secondary outcome [2] 348282 0
Quality of Life (self administered): Measured by a validated tool Kidney Disease Quality of Life (incorporating Short Form 36 (SF-36))
Timepoint [2] 348282 0
Measured at the end of the feasibility study, i.e. at 8 weeks following kidney transplant
Secondary outcome [3] 348283 0
Exploratory variables: Gastrointestinal symptoms: Measured by a validated tool (Gastroninestinal Symtoms Rating Scale (GSRS)
Timepoint [3] 348283 0
Measured at the end of the feasibility study, i.e. at 8 weeks following kidney transplant

Eligibility
Key inclusion criteria
Received an acute kidney transplant at the Princess Alexandra Hospital
Aged equal to or greater than 18 years
Able to provide informed consent
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous renal transplant or a clinically significant change in their immunosuppressant dose within six months determined by the medical team
Receiving/ or have received radiation to the bowel or large bowel resection
Received prebiotic, probiotic or anti-biotic therapy within 1 month of study commencement
Non-English speaking
Unable/unwilling to comply with frequent follow-up
Medically diagnosed and active Irritable Bowel Syndrome
Life expectancy limited due to pre-existing malignancy or other disease (<6 months)
Likely to progress to dialysis within 6 months as determined by the treating physician
Likely transplant recipient within 6 months
Pregnancy
Severely malnourished (Subjective Global Assessment: C)
Chronic Liver disease
Active crohns or ulcerative colitis
Enrolled in another intervention study

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)
Numbered containers
Participants will be given numbered containers (either containing prebiotic active, or prebiotic placebo). This allocation concealment will reduce bias occurring in the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
1:1 randomisation between prebiotic and control will be performed using a computer-generated random allocation sequence.
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
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Data will be analysed via descriptive statistics, expressing frequencies (percentages) for categorical data, mean ± standard deviation for continuous normally distributed data, or median [interquartile range] for continuous non-normally distributed data. In addition, confidence intervals will be presented for all descriptive statistics.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 11181 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 23022 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 299824 0
Hospital
Name [1] 299824 0
Princess Alexandra Hospital
Address [1] 299824 0
Department of Nephrology | Division of Medicine
Metro South Hospital and Health Service | Queensland Government
ARTS Building | Princess Alexandra Hospital
199 Ipswich Road | Woolloongabba Qld 4102
AUSTRALIA
Country [1] 299824 0
Australia
Primary sponsor type
Hospital
Name
Princess Alexandra Hospital
Address
Department of Nephrology | Division of Medicine
Metro South Hospital and Health Service | Queensland Government
ARTS Building | Princess Alexandra Hospital
199 Ipswich Road | Woolloongabba Qld 4102
AUSTRALIA
Country
Australia
Secondary sponsor category [1] 299179 0
University
Name [1] 299179 0
The University of Queensland
Address [1] 299179 0
Faculty of Medicine
The University of Queensland
Herston Campus
Herston, QLD, 4029
Country [1] 299179 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 300704 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 300704 0
Metro South Hospital and Health Service | Queensland Government
Centres for Health Research
Level 7, Translational Research Institute
37 Kent Street
Woolloongabba QLD 4102
Ethics committee country [1] 300704 0
Australia
Date submitted for ethics approval [1] 300704 0
09/07/2018
Approval date [1] 300704 0
Ethics approval number [1] 300704 0

Summary
Brief summary
The Transplantation Standardised Outcomes of Nephrology initative has identified infection as a core outcome. Infections are a common complication following kidney transplantation, occurring in more than 65% KTR in Australia, and 40-50% of transplant recipients worldwide. It is expected that the burden of infectious complications will continue to rise based on the growing prevalence of diabetes mellitus and increasing potency of immunosuppressive regimens.

Infectious complications following kidney transplantation are associated with significant mortality. Infection-related mortality occurs in approximately 15-20% of KTR worldwide. In Australia, infection accounts for approximately 22% of deaths in the KTR population, with 75% of these deaths occurring in individuals with a functioning graft.

Infectious complications are associated with prolonged length of hospital stay, admission to intensive care unit and post-acute care, and early hospital readmission. Treating infectious complications following kidney transplantation has been estimated to cost the Australian Government approximately $8 billion between 2009 and 2020, and places additional strain on healthcare providers. The development of strategies to mitigate infectious complications following kidney transplantation is therefore of great importance.

It has been hypothesised that an individual’s gastrointestinal microbiota may modify the risk of infectious complications in KTR. A study of ileal microbiota from nineteen small bowel transplant recipients has highlighted that the relative compositions of multiple bacterial taxa were diagnostic of infectious illness and acute rejection. Additionally, marked disruption of intestinal flora in human recipients of allogenic stem cell grafts was informative of the risk for bacteraemia. There has been minimal work done on the microbiota of KTR and the underlying pathogenesis, clinical consequences and potential for therapeutic manipulation are poorly understood.

As the gastrointestinal microbiota is intimately influenced by diet, the discovery of this relationship between the kidney and gastrointestinal microbiota, known as the kidney-gastrointestinal axis, may be a therapeutic opportunity for nutritional intervention. Thus, this study will explore the benefit of manipulation of the gastrointestinal microbiota, via prebiotic supplementation, examining the feasibility of performing a randomised controlled trial of prebiotic supplementation in reducing infections and gastrointestinal upset in kidney transplant recipients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 84538 0
Dr Samuel Chan
Address 84538 0
Department of Nephrology | Division of Medicine
Metro South Hospital and Health Service | Queensland Government
ARTS Building | Princess Alexandra Hospital
199 Ipswich Road | Woolloongabba Qld 4102
AUSTRALIA
Country 84538 0
Australia
Phone 84538 0
+61 7 3176 5080
Fax 84538 0
+61 7 3176 5480
Email 84538 0
samuel.chan@uqconnect.edu.au
Contact person for public queries
Name 84539 0
Dr Samuel Chan
Address 84539 0
Department of Nephrology | Division of Medicine
Metro South Hospital and Health Service | Queensland Government
ARTS Building | Princess Alexandra Hospital
199 Ipswich Road | Woolloongabba Qld 4102
AUSTRALIA
Country 84539 0
Australia
Phone 84539 0
+61 7 3176 5080
Fax 84539 0
+61 7 3176 5480
Email 84539 0
samuel.chan@uqconnect.edu.au
Contact person for scientific queries
Name 84540 0
Dr Samuel Chan
Address 84540 0
Department of Nephrology | Division of Medicine
Metro South Hospital and Health Service | Queensland Government
ARTS Building | Princess Alexandra Hospital
199 Ipswich Road | Woolloongabba Qld 4102
AUSTRALIA
Country 84540 0
Australia
Phone 84540 0
+61 7 3176 5080
Fax 84540 0
+61 7 3176 5480
Email 84540 0
samuel.chan@uqconnect.edu.au

No information has been provided regarding IPD availability
Summary results
No Results