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

Overview

Journal Pilot Feasibility Stud

Publisher Biomed Central

Date 2023 Jan 16

PMID 36647175

Authors

Samuel Chan

Carmel M Hawley

Elaine M Pascoe

Christopher Cao

Katrina L Campbell

Scott B Campbell

Ross S Francis

Rachael Hale

Nicole M Isbel

Mark Morrison

David W Johnson

Affiliations

Soon will be listed here.

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 .

Citing Articles

Synbiotics, prebiotics and probiotics for people with chronic kidney disease.

Cooper T, Khalid R, Chan S, Craig J, Hawley C, Howell M Cochrane Database Syst Rev. 2023; 10:CD013631.

PMID: 37870148 PMC: 10591284. DOI: 10.1002/14651858.CD013631.pub2.

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