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Trial record 67 of 561 for:    maltodextrin

Effect of Probiotic Consumption on Chronic Kidney Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03400228
Recruitment Status : Completed
First Posted : January 17, 2018
Last Update Posted : January 17, 2018
Sponsor:
Information provided by (Responsible Party):
Thaís Rodrigues Moreira, Centro Universitário Univates

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

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.




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



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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03400228


Locations
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Brazil
Thaís Rodrigues Moreira
Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
Sponsors and Collaborators
Centro Universitário Univates
Investigators
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Principal Investigator: Thais Rodrigues, Moreira university

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Responsible Party: Thaís Rodrigues Moreira, Principal Investigator, Centro Universitário Univates
ClinicalTrials.gov Identifier: NCT03400228     History of Changes
Other Study ID Numbers: 072015
First Posted: January 17, 2018    Key Record Dates
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:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency