TY - JOUR
T1 - Prebiotic Supplementation in Kidney Transplant Recipients for Preventing Infections and Gastrointestinal Upset: A Randomized Controlled Feasibility Study
AU - Chan, Samuel
AU - Hawley, Carmel M
AU - Pascoe, Elaine M
AU - Cao, Christopher
AU - Campbell, Scott B
AU - Campbell, Katrina L
AU - Francis, Ross S
AU - Hale, Rachael
AU - Isbel, Nicole M
AU - Morrison, Mark
AU - Johnson, David W
N1 - Funding Information:
Financial Disclosure: 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 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 GlaxoSmithKLline 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 Astra Zeneca 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. The remaining authors have no conflicts of interest to declare with respect to the context and scope of this manuscript.The Translational Research Institute is supported by a grant from the Australian Government. Supplementary data related to this article can be found at https://doi.org/10.1053/j.jrn.2022.02.006. Ethical approval was granted through the Metro South Human Research Ethics Committee (HREC/2020/QMS/51887) and The University of Queensland Human Research Ethics Committee, and each participant gave written informed consent. This study was registered with the Australian New Zealand Clinical Trials Registry on the 19 June 2018 (ACTRN12618001057279). Support: This study was funded by the Metro South Research Support Scheme Project Grant.
Funding Information:
The Translational Research Institute is supported by a grant from the Australian Government .
Funding Information:
Financial Disclosure: 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 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 GlaxoSmithKLline 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 Astra Zeneca 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. The remaining authors have no conflicts of interest to declare with respect to the context and scope of this manuscript.
Funding Information:
Support: This study was funded by the Metro South Research Support Scheme Project Grant.
Publisher Copyright:
© 2022 The Authors
PY - 2022/11
Y1 - 2022/11
N2 - BACKGROUND: Modulating the large intestinal microbiome of kidney transplant recipients (KTR) may reduce infectious complications. The aim of this study was to assess the feasibility of a randomized controlled trial of prebiotics in reducing infections and gastrointestinal symptoms in KTR.METHODS: Acute KTR were recruited to a double-blind, placebo-controlled, randomized trial at a single kidney transplant center. Patients were provided with prebiotics or placebo for 7 weeks. The primary outcome was feasibility, defined as recruitment of ≥80% of eligible people within 6 months. Secondary outcomes included adherence and tolerability, participant retention in trial, proportions of participants providing serum and stool specimens, self-reported quality of life (QOL), gastrointestinal symptoms and infection events.RESULTS: During the 7-week period, 72 patients met eligibility criteria, of whom 60 (83%) consented to participate (mean±SD age 53±12 years; 62% males). Fifty six (78%) participants were randomized (27 intervention and 29 control). While participants receiving intervention experienced reduced gastrointestinal symptoms (-0.28 [IQR -0.67 to 0.08] vs -0.07 [IQR -0.27 to 0], p=0.03), both control and intervention groups were similar in adherence (67% vs. 72%, p=0.36), tolerability (56% vs. 62%, p=0.64), QOL (-0.2 [IQR -0.6 to 0] vs. -0.2 [IQR -0.8 to 0], p=0.82) and infection events (33% vs. 34%, p=0.83). Blood and stool samples were collected from ≥90% of participants in both groups.CONCLUSIONS: It is feasible to recruit and retain acute KTR in a randomized placebo-controlled trial examining the effect of prebiotics on infections and gastrointestinal symptoms. This study also showed that prebiotics significantly reduced gastrointestinal symptoms.
AB - BACKGROUND: Modulating the large intestinal microbiome of kidney transplant recipients (KTR) may reduce infectious complications. The aim of this study was to assess the feasibility of a randomized controlled trial of prebiotics in reducing infections and gastrointestinal symptoms in KTR.METHODS: Acute KTR were recruited to a double-blind, placebo-controlled, randomized trial at a single kidney transplant center. Patients were provided with prebiotics or placebo for 7 weeks. The primary outcome was feasibility, defined as recruitment of ≥80% of eligible people within 6 months. Secondary outcomes included adherence and tolerability, participant retention in trial, proportions of participants providing serum and stool specimens, self-reported quality of life (QOL), gastrointestinal symptoms and infection events.RESULTS: During the 7-week period, 72 patients met eligibility criteria, of whom 60 (83%) consented to participate (mean±SD age 53±12 years; 62% males). Fifty six (78%) participants were randomized (27 intervention and 29 control). While participants receiving intervention experienced reduced gastrointestinal symptoms (-0.28 [IQR -0.67 to 0.08] vs -0.07 [IQR -0.27 to 0], p=0.03), both control and intervention groups were similar in adherence (67% vs. 72%, p=0.36), tolerability (56% vs. 62%, p=0.64), QOL (-0.2 [IQR -0.6 to 0] vs. -0.2 [IQR -0.8 to 0], p=0.82) and infection events (33% vs. 34%, p=0.83). Blood and stool samples were collected from ≥90% of participants in both groups.CONCLUSIONS: It is feasible to recruit and retain acute KTR in a randomized placebo-controlled trial examining the effect of prebiotics on infections and gastrointestinal symptoms. This study also showed that prebiotics significantly reduced gastrointestinal symptoms.
UR - http://www.scopus.com/inward/record.url?scp=85127347026&partnerID=8YFLogxK
U2 - 10.1053/j.jrn.2022.02.006
DO - 10.1053/j.jrn.2022.02.006
M3 - Article
C2 - 35248721
SN - 1051-2276
VL - 32
SP - 718
EP - 725
JO - Journal of Renal Nutrition
JF - Journal of Renal Nutrition
IS - 6
ER -