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

Pilot and Feasibility Studies

Study Protocol

Katrina L. Campbell¹  Rachael Hale²  Christopher Cao²  Scott B. Campbell³  Elaine M. Pascoe³  Carmel M. Hawley³  David W. Johnson³  Ross S. Francis³  Nicole M. Isbel³  Samuel Chan³  Mark Morrison⁴ 

[1] Australasian Kidney Trials Network, The University of Queensland, Brisbane, Queensland, Australia;Department of Nephrology, Princess Alexandra Hospital, Woolloongabba, Queensland, Australia;Department of Nephrology, Princess Alexandra Hospital, Woolloongabba, Queensland, Australia;Australasian Kidney Trials Network, The University of Queensland, Brisbane, Queensland, Australia;Translational Research Institute, Brisbane, Queensland, Australia;The University of Queensland Diamantina Institute, Faculty of Medicine, University of Queensland, Woolloongabba, Queensland, Australia;

关键词: Adherence;    Clinical trial;    Feasibility;    Gut microbiota;    Kidney failure;    Kidney transplantation;    Prebiotics;    Recruitment;    Tolerance;   

DOI  :  10.1186/s40814-023-01236-y

 received in 2021-01-13, accepted in 2023-01-02,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundModulating 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.MethodsSixty 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.DiscussionThis 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 registrationAustralian 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.

【 授权许可】

CC BY   
© The Author(s) 2023

【 图 表 】

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