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临床试验/NCT03400228
NCT03400228已完成不适用

Effect of Probiotic Consumption on Chronic Kidney Disease and Cardiovascular Risk

Centro Universitário Univates2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2015年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
2
主要终点
Decrease in serum creatinine level

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

Protics

Experimental

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

干预措施: Probiotic (Dietary Supplement)

Placebo

Placebo Comparator

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

干预措施: Maltodextrin (Dietary Supplement)

结局指标

主要结局

Decrease in serum creatinine level

时间窗: 24 weeks

Reduction of serum creatinine level

次要结局

  • Reduced levels of serum lipids(24 weeks)

研究者

发起方
Centro Universitário Univates
申办方类型
Other
责任方
Principal Investigator
主要研究者

Thaís Rodrigues Moreira

Principal Investigator

Centro Universitário Univates

研究点 (2)

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