ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12618001057279

Ethics application status

Approved

Date submitted

19/06/2018

Date registered

25/06/2018

Date last updated

25/03/2021

Date data sharing statement initially provided

4/09/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

Prospective randomised evaluation of prebiotics in organ transplantation to prevent infectious complications - feasibility study

Scientific title

Prospective randomised evaluation of prebiotics in organ transplantation to prevent infectious complications

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

PREBIOTIC

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Kidney disease

Kidney transplant

Condition category

Condition code

Renal and Urogenital

Kidney disease

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Participants will be given information about the study while an inpatient in the transplant ward. They will be given the opportunity to ask questions, to take the information home with them when they leave the hospital and to discuss it with friends, family or others. They will be able to inform us about whether or not they wish to participate at one of their routine clinic visits in the early post-discharge period. This will ensure that the patients are well, stable and able to fully consider their participation in the study.
Participants will be provided with a prebiotic powder or placebo (powder) for eight weeks duration. This will commence when patients are discharged to the outpatient setting following their acute kidney transplant usually a window period of day 5 to day 12. The prebiotic powder will be Green Banana Multi-Resistant Starch which will be provided in-kind by Natural Evolutions (Walkamin, Australia). The placebo will be matched powder (waxy maize, Bulk Nutrients, Grove, Tasmania, Australia). The prebiotic will be administered orally as a powder suspended in water. 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 exact dose will be 7.5g daily for the first two weeks, and then progress to 15g daily for the final six weeks of the study.

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

Placebo: matched powder: waxy maize

Control group

Placebo

Outcomes

Primary outcome [1]

This is not the primary outcome
The primary outcome for this study is feasibility
a) ability to successfully recruit 60 patients within six months
b) proportion of eligible patients who agree to take part in the study

This will be assessed at the end of the clinical trial

Timepoint [1]

Adherence to the Green Banana Resistant Starch will be assessed at the end of the study. The adherence parameter will be measured at the end of the study, i.e. at the eight week mark after kidney transplantation
This will be a secondary outcome now
Adherence to prebiotic supplementation will be defined as
a) proportion of participants adherent to prescribed study therapy (intervention or placebo) over the period of the study

Secondary outcome [1]

Laboratory testing
a) proportion of participants providing two stool samples at designated times (the first week and between week four to week eight post kidney transplant) to assess gut microbiota changes (stool sample analysis via shotgun metagenomic sequencing to a target depth of 3Gbp using NovaSeq 6000, 2x150bp paired-end chemistry)

b) proportion of participants providing two blood samples at designated times (the first week and week eight post kidney transplant)

Timepoint [1]

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]

Consumer-centred outcomes
a) Changes in the overall quality of life (measured by EQ-5D survey)

Timepoint [2]

Measured at the start and at the end of the feasibility study i.e. at baseline and at 8 weeks following kidney transplant

Secondary outcome [3]

Tolerance
a) proportion of patients who continue the prebiotic supplementation
b) changes in the Gastrointestinal Symptom Rating Scale

Timepoint [3]

Measured at the start, at Week 2 and at the end of the feasibility study i.e. at baseline and at 8 weeks following kidney transplant

Secondary outcome [4]

Clinical outcomes
a) proportion of patients with at least one infectious event (infectious event is anything requiring admission or antimicrobial therapy)
b) episodes of rejection and death

Timepoint [4]

This will be collected and will be included under 'clinical outcomes' as above.

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

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Have received radiation to the bowel or large bowel resection
Unable to comply with follow-up
Medically diagnosed and active inflammatory bowel disease
Unwilling or unable to meet the requirements of the protocol
Other medical or social reasons for exclusion at the discretion of the investigators.

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)

Allocation will be via sealed opaque envelopes

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

1:1 randomisation between prebiotic and control; randomisation will be prepared by a researcher not involved with treatment allocation and will involve stratification factors of age (<65 years, >=65 years) and sex.

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

Recruiting

Date of first participant enrolment

Anticipated

12/10/2020

Actual

12/10/2020

Date of last participant enrolment

Anticipated

30/04/2021

Actual

Date of last data collection

Anticipated

30/06/2021

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

Princess Alexandra Hospital - Woolloongabba

Recruitment postcode(s) [1]

4102 - Woolloongabba

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Metro South Hospital and Health Service Research Support Scheme

Address [1]

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]

Australia

Primary sponsor type

Hospital

Name

Princess Alexandra Hospital

Address

Country

Australia

Secondary sponsor category [1]

University

Name [1]

The University of Queensland

Address [1]

Faculty of Medicine
The University of Queensland
Herston Campus
Herston, QLD, 4029

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Metro South Human Research Ethics Committee

Ethics committee address [1]

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]

Australia

Date submitted for ethics approval [1]

14/10/2019

Approval date [1]

29/05/2020

Ethics approval number [1]

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

Dr Samuel Chan

Address

Country

Australia

Phone

+61 7 3176 5080

Fax

+61 7 3176 5480

[email protected]

Contact person for public queries

Name

Samuel Chan

Address

Country

Australia

Phone

+61 7 3176 5080

Fax

+61 7 3176 5480

[email protected]

Contact person for scientific queries

Name

Samuel Chan

Address

Country

Australia

Phone

+61 7 3176 5080

Fax

+61 7 3176 5480

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

Will need to be discussed with the ethics committee first

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

Source	Title	Year of Publication	DOI
Embase	PREBIOTIC: a study protocol of a randomised controlled trial to assess prebiotic supplementation in kidney transplant recipients for preventing infections and gastrointestinal upset - a feasibility study.	2023	https://dx.doi.org/10.1186/s40814-023-01236-y

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically