Skip to main content
OpenTrials
Completed

NCT Number: NCT03400228

Effect of Probiotic Consumption on Chronic Kidney Disease

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Thaís Rodrigues Moreira

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Probiotic

Dietary Supplement

The probiotic is composed of a combination of Lactobacillus acidophilus (LA-5®) and Bifidobacterium lactis (BB-12®).

Maltodextrin

Dietary Supplement

Maltodextrin is a supplement feed based carbohydrate powder and tasteless.

Primary outcomes

  1. Decrease in serum creatinine level

    Time frame: 24 weeks

    Reduction of serum creatinine level

Secondary outcomes

  1. Reduced levels of serum lipids

    Time frame: 24 weeks

    Reduced serum cholesterol level

Sponsors and collaborators

Lead sponsor

Centro Universitário Univates

Other

Registry information

Official study title

Effect of Probiotic Consumption on Chronic Kidney Disease and Cardiovascular Risk

Important dates

Study start
2015
Primary completion
2015
Study completion
2017
First posted
Jan 17, 2018
Registry last updated
Jan 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.