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. 2023 Jan 16;9(1):11.
doi: 10.1186/s40814-023-01236-y.

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

Samuel Chan  1   2   3 , Carmel M Hawley  4   5   6 , Elaine M Pascoe  4   5   6 , Christopher Cao  4 , Katrina L Campbell  5 , Scott B Campbell  4   5   6 , Ross S Francis  4   5   6 , Rachael Hale  4 , Nicole M Isbel  4   5   6 , Mark Morrison  7 , David W Johnson  4   5   6
Affiliations

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

Samuel Chan et al. Pilot Feasibility Stud. .

Abstract

Background: Modulating the microbiota in the large intestine of kidney transplant recipients through prebiotic supplementation may prevent infectious complications from occurring. To date, there have been no interventional trials which have investigated this novel treatment in kidney transplantation. The aim of PREBIOTIC is to assess the feasibility of performing a randomised controlled trial of prebiotics in reducing infections and gastrointestinal symptoms in kidney transplant recipients.

Methods: Sixty kidney transplant patients will be recruited to a double-blind, placebo-controlled, randomised feasibility trial. Patients will be provided with prebiotic therapy or placebo for 4 to 6 weeks. Outcomes will include recruitment, adherence, tolerance, retention, laboratory parameters (including serum indoxyl sulphate, ρ-cresyl sulphate and stool collection), patients' self-assessed quality of life, gastrointestinal symptoms and clinical outcomes.

Discussion: This trial will assess the feasibility of prebiotic supplementation in kidney transplant recipients. Prebiotics not only may alter the gut microbiota and their inherent metabolism and production of uraemic toxins but also may prevent infections from occurring in kidney transplant recipients.

Trial registration: Australian New Zealand Clinical Trials Registry number ACTRN12618001057279p. The date of registration was 25th June 2018, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=375370&isReview=true .

Keywords: Adherence; Clinical trial; Feasibility; Gut microbiota; Kidney failure; Kidney transplantation; Prebiotics; Recruitment; Tolerance.

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Conflict of interest statement

Samuel Chan is supported by the Australian National Health and Medical Research Council (NHMRC) Postgraduate Scholarship, the Microba recipient grant, the Metro South Research Support Scheme and the Royal Australasian College of Physicians NHMRC Jacquot Research Excellence top-up award. Furthermore, Dr. Chan is a current recipient of the 2018 Sir Gustav Nossal NHMRC Postgraduate Scholarship award. Carmel Hawley is the recipient of research grants paid to her institution from Baxter Healthcare and Fresenius Medical Care and from Otsuka, Janssen and GlaxoSmithKline for trial steering committee activities, paid to her institution. David Johnson has received consultancy fees, research grants, speaker’s honoraria and travel sponsorships from Baxter Healthcare and Fresenius Medical Care. He has received consultancy fees from AstraZeneca, Bayey and AWAK, speaker’s honoraria from Ono, and travel sponsorships from Amgen. He is a current recipient of an Australian NHMRC Practitioner Fellowship. Nicole Isbel has received consultancy fees and speaker’s honoraria from Alexion Pharmaceuticals, Novo Nordisk and Amgen. Katrina Campbell has received consultancy fees from Nestle Health Sciences and speaker’s honoraria from Amgen. The remaining authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
PREBIOTIC study schema
See this image and copyright information in PMC

References

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    1. Australian Bureau of Statistics . Causes of death, 2016- disease of the kidney, urinary system and genitals (N00-N99) Australia: Australian Bureau of Statistics; 2017.
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