Effect of Probiotic Consumption on Chronic Kidney Disease

NCT ID: NCT03400228

Last Updated: 2018-01-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-01
• Study Completion Date: 2017-12-31

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.

Conditions

Chronic Kidney Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Protics

Patients in the intervention group were to drink 2 sachets of 1g of probiotic daily for 24 weeks

Group Type: EXPERIMENTAL

Probiotic

Intervention Type: DIETARY_SUPPLEMENT

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

Placebo

Patients in the intervention group were to drink 2 sachets of 1g of maltodextrin daily for 24 weeks

Group Type: PLACEBO_COMPARATOR

Maltodextrin

Intervention Type: DIETARY_SUPPLEMENT

Maltodextrin is a supplement feed based carbohydrate powder and tasteless.

Interventions

Probiotic

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

Intervention Type: DIETARY_SUPPLEMENT

Maltodextrin

Maltodextrin is a supplement feed based carbohydrate powder and tasteless.

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centro Universitário Univates

OTHER

Sponsor Role: lead

Responsible Party

Thaís Rodrigues Moreira

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thais Rodrigues, Moreira

Role: PRINCIPAL_INVESTIGATOR

university

Locations

Thaís Rodrigues Moreira

Porto Alegre, Rio Grande do Sul, Brazil

Countries

Brazil

Other Identifiers

072015

Identifier Type: -

Identifier Source: org_study_id