Investigating the feasibility and acceptability of synbiotic supplementation in patients with chronic kidney disease (pre-dialysis)
- Conditions
- Chronic Kidney DiseaseRenal and Urogenital - Kidney diseaseDiet and Nutrition - Other diet and nutrition disorders
- Registration Number
- ACTRN12617000324314
- Lead Sponsor
- A/Prof Katrina Campbell
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 68
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
- 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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Feasibility and acceptability of long-term synbiotic supplementation in patients. Assessed as a composite of;<br>1. recruitment rate<br>2. retention rate<br>3. adherence to study product - product dispensed compared with product returned<br>4. acceptability - qualitative interviews with participants to explore their experience and acceptability of synbiotic supplementation.[Baseline and end of intervention (week 52)]
- Secondary Outcome Measures
Name Time Method