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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03400228
Other study ID # 072015
Secondary ID
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
Health authority
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.

Study Design


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
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