Effect of Probiotic Consumption on Chronic Kidney Disease

Effect of Probiotic Consumption on Chronic Kidney Disease and Cardiovascular Risk

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.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Disease
• Intervention / Treatment: Dietary supplement: Probiotic; Dietary supplement: Maltodextrin

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
      • Thaís Rodrigues Moreira

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Protics; Patients in the intervention group were to drink 2 sachets of 1g of probiotic daily for 24 weeks	Dietary supplement: Probiotic; The probiotic is composed of a combination of Lactobacillus acidophilus (LA-5®) and Bifidobacterium lactis (BB-12®).
Placebo Comparator: Placebo; Patients in the intervention group were to drink 2 sachets of 1g of maltodextrin daily for 24 weeks	Dietary supplement: Maltodextrin; Maltodextrin is a supplement feed based carbohydrate powder and tasteless.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decrease in serum creatinine level	Reduction of serum creatinine level	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduced levels of serum lipids	Reduced serum cholesterol level	24 weeks

Collaborators and Investigators

• Sponsor: Centro Universitário Univates
• Investigators: Principal Investigator: Thais Rodrigues, Moreira, University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2015
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): December 31, 2017

Study Registration Dates

• First Submitted: January 8, 2018
• First Submitted That Met QC Criteria: January 12, 2018
• First Posted (Actual): January 17, 2018

Study Record Updates

• Last Update Posted (Actual): January 17, 2018
• Last Update Submitted That Met QC Criteria: January 12, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Probiotics; Chronic kidney disease; Cardiovascular risk
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: 072015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: There is no plan to make available individual participant data (IPD) to other researchers.