None listed
Conditions
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.
Interventions
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 t
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.
Sponsors
Princess Alexandra Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
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.
Outcome results
None listed