Chronic Kidney Disease
Conditions
Keywords
Probiotics, Chronic kidney disease, Cardiovascular risk
Brief summary
Recent studies have demonstrated that the balance of intestinal microbiota is affected in chronic kidney disease (CKD), leading to a condition known as intestinal dysbiosis. These changes were associated with metabolic complications, accumulation of uremic toxins, inflammation, progression of CKD and cardiovascular risk. Measures with the aim of restore the balance of intestinal flora are suggested, such as the intake of probiotics composed of beneficial bacteria, but few studies have discussed the effect of these supplements in CKD. The present study aims to evaluate the effect of consumption of probiotics in factors associates with progression of CKD and cardiovascular risk. To such will be conducted a double-blind, placebo-controlled, and randomized clinical trial with 30 patients with CKD in stages 3-5, treated in ambulatories of Nephrology of the Hospital de Clínicas de Porto Alegre, independently of etiology and with steady renal function. Patients will be excluded whether in substitutive renal therapy, kidney transplant, on antimicrobial therapy or immunosuppressive agents in the last three months or with acute clinical events. The assessment will include clinical and nutritional parameters, estimated glomerular filtration rate, proteinuria, serum lipids, inflammatory factors, and bowel habits. The study protocol includes the recruitment of patients who will undergo to 4-week washout period. After patients will be randomized and provided with probiotic therapy (intervention group) or placebo (maltodextrin; control group) for 24 weeks. All patients will be instructed to consume 2 sachets/day of probiotic or placebo and receive nutritional advice. All data will be analysed by the principal investigator with the support of a trained statistician and the chief investigator. The statistical programme SPSS will be used.
Detailed description
The assessment will include clinical and nutritional parameters, estimated glomerular filtration rate, proteinuria, serum lipids, inflammatory factors, and bowel habits. The study protocol includes the recruitment of patients who will undergo to 4-week washout period. After patients will be randomized and provided with probiotic therapy (intervention group) or placebo (maltodextrin; control group) for 24 weeks. All patients will be instructed to consume 2 sachets/day of probiotic or placebo and receive nutritional advice.
Interventions
DIETARY_SUPPLEMENTProbiotic
The probiotic is composed of a combination of Lactobacillus acidophilus (LA-5®) and Bifidobacterium lactis (BB-12®).
DIETARY_SUPPLEMENTMaltodextrin
Maltodextrin is a supplement feed based carbohydrate powder and tasteless.
Sponsors
Centro Universitário Univates
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with chronic kidney disease stage 3, 4 and 5; * Stable renal function; * Proteinuria greater than or equal to 500 mg; * Patients who agree to participate.
Exclusion criteria
* Patients on renal replacement therapy or kidney transplant; * Patients with prior renal transplant; * Patients with acute clinical events; * Patients using antibiotics or any other medications that can alter the intestinal microbiota as corticosteroids and immunosuppressants in the last three months; * Patients with active infection; * Patients with inflammatory bowel diseases or malabsorption; * Acute or chronic diarrhea; * Patients with previous intestinal surgery; * Pregnants.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Decrease in serum creatinine level | 24 weeks | Reduction of serum creatinine level |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reduced levels of serum lipids | 24 weeks | Reduced serum cholesterol level |
Countries
Brazil
Outcome results
None listed