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Effect of Probiotic Consumption on Chronic Kidney Disease

Primary Purpose

Chronic Kidney Disease

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Probiotic
Maltodextrin
Sponsored by
Centro Universitário Univates
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chronic Kidney Disease focused on measuring Probiotics, Chronic kidney disease, Cardiovascular risk

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Thaís Rodrigues Moreira

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Protics

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Decrease in serum creatinine level
Reduction of serum creatinine level

Secondary Outcome Measures

Reduced levels of serum lipids
Reduced serum cholesterol level

Full Information

First Posted
January 8, 2018
Last Updated
January 12, 2018
Sponsor
Centro Universitário Univates
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1. Study Identification

Unique Protocol Identification Number
NCT03400228
Brief Title
Effect of Probiotic Consumption on Chronic Kidney Disease
Official Title
Effect of Probiotic Consumption on Chronic Kidney Disease and Cardiovascular Risk
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
July 1, 2015 (Actual)
Primary Completion Date
July 1, 2015 (Actual)
Study Completion Date
December 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centro Universitário Univates

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
Keywords
Probiotics, Chronic kidney disease, Cardiovascular risk

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Protics
Arm Type
Experimental
Arm Description
Patients in the intervention group were to drink 2 sachets of 1g of probiotic daily for 24 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients in the intervention group were to drink 2 sachets of 1g of maltodextrin daily for 24 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic
Intervention Description
The probiotic is composed of a combination of Lactobacillus acidophilus (LA-5®) and Bifidobacterium lactis (BB-12®).
Intervention Type
Dietary Supplement
Intervention Name(s)
Maltodextrin
Intervention Description
Maltodextrin is a supplement feed based carbohydrate powder and tasteless.
Primary Outcome Measure Information:
Title
Decrease in serum creatinine level
Description
Reduction of serum creatinine level
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Reduced levels of serum lipids
Description
Reduced serum cholesterol level
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thais Rodrigues, Moreira
Organizational Affiliation
university
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thaís Rodrigues Moreira
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90035-903
Country
Brazil

12. IPD Sharing Statement

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

Learn more about this trial

Effect of Probiotic Consumption on Chronic Kidney Disease

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