Effect of Probiotic Consumption on Chronic Kidney Disease

• ClinicalTrials.gov Identifier: NCT03400228
• Recruitment Status: Completed
• First Posted: January 17, 2018
• Last Update Posted: January 17, 2018
• Sponsor: Centro Universitário Univates
• Information provided by (Responsible Party): Thaís Rodrigues Moreira, Centro Universitário Univates

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Chronic Kidney Disease	Dietary Supplement: Probiotic; Dietary Supplement: Maltodextrin	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Other
• Official Title: Effect of Probiotic Consumption on Chronic Kidney Disease and Cardiovascular Risk
• Actual Study Start Date: July 1, 2015
• Actual Primary Completion Date: July 1, 2015
• Actual Study Completion Date: December 31, 2017

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Decrease in serum creatinine level [ Time Frame: 24 weeks ]
   Reduction of serum creatinine level

Secondary Outcome Measures :

1. Reduced levels of serum lipids [ Time Frame: 24 weeks ]
   Reduced serum cholesterol level

Eligibility Criteria

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

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.

Contacts and Locations

Locations

Brazil

Thaís Rodrigues Moreira

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

Sponsors and Collaborators

Centro Universitário Univates

Investigators

• Principal Investigator: Thais Rodrigues, Moreira; university

More Information

• Responsible Party: Thaís Rodrigues Moreira, Principal Investigator, Centro Universitário Univates
• ClinicalTrials.gov Identifier: NCT03400228
• Other Study ID Numbers: 072015
• First Posted: January 17, 2018
• Last Update Posted: January 17, 2018
• Last Verified: January 2018

Individual Participant Data (IPD) Sharing Statement:

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

Keywords provided by Thaís Rodrigues Moreira, Centro Universitário Univates:

Probiotics; Chronic kidney disease; Cardiovascular risk

Additional relevant MeSH terms:

Kidney Diseases; Renal Insufficiency, Chronic; Urologic Diseases; Renal Insufficiency