None listed
Conditions
Brief summary
This study aims to assess the effect co-administration of pre- and probiotics has on cardiovascular risk in patients with chronic kidney disease, and, whether this is a potential treatment strategy targeting the deleterious side effects of uraemic toxins.
Interventions
This is a 12-month intervention where patients will be randomised to either intervention or control group. The intervention group will receive prebiotic and probiotics alongside healthy eating for CKD education. Dietary education will be a minimum of 30 minutes in duration and will be based on the Evidence Based Practice Guidelines for the Nutritional Management of Chronic Kidney Disease. Individual, face to face sessions will be conducted by an Accredited Practicing Dietitian who specialises in
This is a 12-month intervention where patients will be randomised to either intervention or control group. The intervention group will receive prebiotic and probiotics alongside healthy eating for CKD education. Dietary education will be a minimum of 30 minutes in duration and will be based on the Evidence Based Practice Guidelines for the Nutritional Management of Chronic Kidney Disease. Individual, face to face sessions will be conducted by an Accredited Practicing Dietitian who specialises in renal nutrition. During these sessions, the patient will be provided with a pamphlet (from Queensland Health Nutrition Education Materials Online) which outlines key information pertaining to healthy eating for CKD. This will be discussed in detail with the patient, allowing for clarification of any unclear messages. These sessions will occur alongside scheduled clinic visits (baseline, weeks 13, 26, 39 and 52). Prebiotic dose = 2 x 10g powder/day. Probiotic dose = 450 billion CFU (1 sachet per day) To be taken in cold non-carbonated drinks or food Intervention fidelity will be monitored through a supplement count and weighing. Adherence to a stable diet will be monitored using 24hr food recalls.Prebiotic dose = 2 x 10g powder/day. Probiotic dose = 450 billion CFU (1 sachet per day) To be taken in cold non-carbonated drinks or food Intervention fidelity will be monitored through a supplement count and weighing. Adherence to a stable diet will be monitored using 24hr food recalls.
Sponsors
A/Prof Katrina Campbell
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
CKD stage III-IV: GFR stable between 15-60 ml/min (for the past 3 months), Under the care of a nephrologist, Able to provide informed consent
Exclusion criteria
- Previous clinically significant change in immunosuppressant dose within six months determined by the medical team - Receiving/or have received radiation to the bowel or large bowel resection - Medically diagnosed and active irritable bowel syndrome, active Crohn’s disease, ulcerative colitis - Cirrhotic liver disease - Received prebiotic, probiotic or anti-biotic therapy within 1 month of study commencement - Unable to understand English - Unable/unwilling to comply with follow-up - Life expectancy limited due to pre-existing malignancy or other disease (<6 months) - Likely to progress to end-stage treatment within 12 months as determined by the treating physician - Pregnancy - Severely malnourished (Subjective Global Assessment: C)
Outcome results
None listed