Clinical trial NCT03400228: Effect of Probiotic Consumption on Chronic Kidney Disease
Official title: Effect of Probiotic Consumption on Chronic Kidney Disease and Cardiovascular Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease
Keywords: Probiotics
Chronic kidney disease
Cardiovascular risk
Lead sponsor: Centro Universitário Univates
Sponsor class: OTHER
First posted: 2018-01-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Decrease in serum creatinine level
timeFrame: 24 weeks
Secondary outcomes:
measure: Reduced levels of serum lipids
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Thaís Rodrigues Moreira
state: Rio Grande Do Sul
Study officials:
affiliation: university
name: Thais Rodrigues, Moreira
role: PRINCIPAL_INVESTIGATOR
References: