Investigating the effect of synbiotics on uremic toxin concentrations in the pre-dialysis population.
Phase 2
Recruiting
- Conditions
- Chronic Kidney DiseaseRenal and Urogenital - Kidney diseaseDiet and Nutrition - Other diet and nutrition disorders
- Registration Number
- ACTRN12613000493741
- Lead Sponsor
- Princess Alexandra Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
*CKD stage IV: GFR stable between 10-30 ml/min/1.73m2 (for the past 3 months)
*Able to provide informed consent
Exclusion Criteria
*Previous transplant or on immunosuppressants
*Receiving/ or have received radiation to the bowel
*Received prebiotic, probiotic or anti-biotic therapy within 1 month of study commencement
*Non-English speaking
*Unable/unwilling to comply with frequent follow-up
*Active medically diagnosed Irritable Bowel Syndrome
*Life expectancy limited due to pre-existing malignancy or other disease (<6 months)
*Likely to progress to dialysis within 6 months as determined by the treating physician
*Likely transplant recipient within 6 months
*Pregnancy
*Severely malnourished (Subjective Global Assessment: C)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Free and protein-bound concentrations of serum- indoxyl sulphate and p-cresyl sulphate[Baseline, mid point (3 weeks) and end of intervention (6 weeks) for each arm]
- Secondary Outcome Measures
Name Time Method Inflammation (serum- CRP, IFN-gamma, TNF-alpha, IL-6) and Oxidative stress (plasma- GPX, MDA and 8-Isoprostanes)[Baseline, mid point (3 weeks) and end of intervention (6 weeks) for each arm];Renal tubule damage & CKD progression<br>Urinary Kidney Injury Molecule1 (KIM1) and slope of reciprocal serum concentration of creatinine and creatinine clearance (24hr urine collection) vs. time plot, proteinuria and eGFR-EPI (Chronic Kidney Disease Epidemiology Collaboration) formula.[Baseline, mid point (3 weeks) and end of intervention (6 weeks) for each arm];Gut microbiota (fecal sample- next generation sequencing)[Baseline and end of intervention (6 weeks) for each arm];Endotoxemia- (plasma lipopolysaccharides)[Baseline, mid point (3 weeks) and end of intervention (6 weeks) for each arm];Quality of Life (KDQOL)[End of intervention (6 weeks) (for each arm)];Dietary compliance- diet history interviews and 24hr recalls[Baseline, mid point (3 weeks) and end of intervention (6 weeks) for each arm]