Probiotic dietary supplementation in patients with stage 3 and 4 chronic kidney disease: a 6-month pilot scale trial in Canada
Probiotic dietary supplementation in patients with stage 3 and 4 chronic kidney disease: a 6-month pilot scale trial in Canada
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DOI：
10.1185/03007990903069249
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发表时间：
2009-08-01
影响因子：
2.3
通讯作者：
Dheer, Rahul
中科院分区：
文献类型：
--
作者：
Ranganathan, Natarajan;Friedman, Eli A.;Dheer, Rahul
目的：这是一项试点临床试验，旨在评估口服益生菌膳食补充剂对慢性肾病 (CKD) 患者（3 期和 4 期）的生化和临床效果。方法：在加拿大安大略省的 16 名门诊患者中进行了一项前瞻性、随机、双盲、交叉、安慰剂对照、为期 6 个月的益生菌试验。主要终点包括对血液学、生化和粪便变量的影响，以及对通过生活质量 (QOL) 评估的总体健康状况的影响。这些结果是根据生化参数进行评估的，主要是血尿素氮 (BUN)、肌酐、尿酸和作为一般炎症标志物的 C 反应蛋白 (CRP)。生活质量以 1 至 10 的主观量表作为次要参数进行评估。试验注册：该试点研究构成注册试验 NCT00760162 的一部分。结果：共有 13 名患者完成了该研究。三名患者退出：其中一名接受了移植手术。第二个因不明原因退出，第三个死于心肌梗塞（与益生菌或方案无关）。在完成试验的 13 名患者中，益生菌治疗期间 BUN 浓度的平均变化 (-2.93 mmol/L) 与安慰剂期间 BUN 浓度的平均变化 (4.52 mmol/L) 显着不同 (p = 0.002)。此外，与安慰剂期间（50.62μmol/L，p=0.050）相比，KB期间尿酸浓度的平均变化（24.70μmol/L）是中等的，并且血清肌酐浓度的变化不显着。在任何 QOL 改善的受试者中，均未发现胃肠道或感染并发症。结论：口服益生菌选择代谢含氮废物的耐受期可长达 6 个月。该试验的一个主要限制是其规模较小，可能无法检测其他生化或血液学参数的变化，而这些变化在较大的队列中会很明显。对这种益生菌混合物的评估的扩展将包括在类似的前瞻性、安慰剂对照和双盲研究中心进行剂量递增试验。
Aim: This was a pilot clinical trial to assess biochemical and clinical effects of an oral probiotic dietary supplement in chronic kidney disease (CKD) patients (stages 3 and 4).Methods: A prospective, randomized, double-blind, crossover, placebo-controlled, 6-month trial of probiotic bacteria was conducted in 16 outpatients in Ontario, Canada. Primary endpoints included effect on hematologic, biochemical, and fecal variables, and on general well-being as assessed by quality of life (QOL). These outcomes were evaluated from biochemical parameters, mainly blood urea nitrogen (BUN), creatinine, uric acid, and C-reactive protein (CRP) as a general inflammatory marker. QOL was assessed on a subjective scale of 1 to 10 as the secondary parameter.Trial registration: This pilot study forms part of registered trial NCT00760162.Results: A total of 13 patients completed the study. Three patients dropped out: one was the receiver of a transplant. The second dropped out for unknown reasons and the third died of myocardial infarction (unrelated to probiotic bacteria or the protocol). Among the 13 patients who completed the trial, the mean change in BUN concentration during the probiotic treatment period (-2.93 mmol/L) differed significantly (p = 0.002) from the mean change in BUN concentration during the placebo period (4.52 mmol/L). In addition, the mean changes in uric acid concentration were moderate during the KB period (24.70 mu mol/L) versus during the placebo period (50.62 mu mol/L, p = 0.050), and the changes in serum creatinine concentration were insignificant. Neither gastrointestinal nor infectious complications were noted in any subject with improved QOL.Conclusion: Orally administered probiotic bacteria selected to metabolize nitrogenous wastes may be tolerated for as long as 6 months. A major limitation of this trial is its small size that may have precluded detection of changes in other biochemical or hematologic parameters that would be evident in larger cohorts. Extension of the evaluation of this probiotic bacterial mixture will include a dose escalation trial in a similar prospective, placebo-controlled, and double-blind study site.