Effect of Probiotic Consumption on Chronic Kidney Disease

Chronic Kidney Disease Clinical Trial

Official title:

Effect of Probiotic Consumption on Chronic Kidney Disease and Cardiovascular Risk

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03400228
• Other study ID #: 072015
• Status: Completed
• Phase: N/A
• First received: January 8, 2018
• Last updated: January 12, 2018
• Start date: July 1, 2015
• Est. completion date: December 31, 2017

Study information

• Verified date: January 2018
• Source: Centro Universitário Univates
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 31, 2017
• Est. primary completion date: July 1, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Dietary Supplement:
• Probiotic
The probiotic is composed of a combination of Lactobacillus acidophilus (LA-5®) and Bifidobacterium lactis (BB-12®).
• Maltodextrin
Maltodextrin is a supplement feed based carbohydrate powder and tasteless.

Locations

Country	Name	City	State
Brazil	Thaís Rodrigues Moreira	Porto Alegre	Rio Grande Do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Centro Universitário Univates

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease in serum creatinine level	Reduction of serum creatinine level	24 weeks
Secondary	Reduced levels of serum lipids	Reduced serum cholesterol level	24 weeks