An open-label, randomized, placebo-controlled study on the effectiveness of a novel probiotics administration protocol (ProbiotiCKD) in patients with mild renal insufficiency (stage 3a of CKD).

An open-label, randomized, placebo-controlled study on the effectiveness of a novel probiotics administration protocol (ProbiotiCKD) in patients with mild renal insufficiency (stage 3a of CKD).
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DOI:
10.1007/s00394-018-1785-z
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发表时间:
2019-08
影响因子:
5
通讯作者:
Fuiano G
Fuiano G
中科院分区:
医学2区
文献类型:
--
作者:
Simeoni M;Citraro ML;Cerantonio A;Deodato F;Provenzano M;Cianfrone P;Capria M;Corrado S;Libri E;Comi A;Pujia A;Abenavoli L;Andreucci M;Cocchi M;Montalcini T;Fuiano G

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肠道生态失调已被描述为晚期,但不是在CKD的初始阶段。考虑到肠道生态失调对肾脏和心血管风险的相关影响,其诊断和治疗具有临床相关性。我们设计了一项开放标签、安慰剂对照干预研究(ProbiotiCKD),以评估基线时和随机分配益生菌或安慰剂治疗后KDIGO CKD患者(n = 28)队列的肠道微生物群代谢。肠道微生物群状态评价:。两组的基础平均粪便乳酸杆菌和双歧杆菌浓度异常低,而尿中的靛聚糖和3-MI水平,表明混合(发酵和腐败)的生态失调。治疗后,仅益生菌组的平均粪便乳酸杆菌和双歧杆菌浓度增加(p < 0.001)。相反,仅在用益生菌治疗的组中平均尿靛聚糖和3-MI水平(p < 0.001)。与安慰剂组相比,仅在益生菌组中观察到C-反应蛋白(p <0.001)、铁(p <0.001)、铁蛋白(p <0.001)、转铁蛋白饱和度(p <0.001)、β2-微球蛋白(p < 0.001)、血清iPTH和血清钙的显著改善。ProbiotiCKD是第一项干预研究,证明即使在早期CKD阶段也存在肠道混合生态失调,并且可以通过高质量益生菌的新给药模式有效纠正,改善炎症指数,铁状态和iPTH稳定。
Gut dysbiosis has been described in advanced, but not in initial stages of CKD. Considering the relevant impact of gut dysbiosis on renal and cardiovascular risk, its diagnosis and treatment are clinically relevant. We designed, open-label, placebo-controlled intervention study (ProbiotiCKD) to evaluate gut microbiota metabolism in a cohort of KDIGO CKD patients (n = 28) at baseline and after a randomly assigned treatment with probiotics or placebo. Gut microbiota status was evaluated on:. Basal mean fecal Lactobacillales and Bifidobacteria concentrations were abnormally low in both groups, while urinary indican and 3-MI levels were, indicating a mixed (fermentative and putrefactive) dysbiosis. After treatment, mean fecal Lactobacillales and Bifidobacteria concentrations were increased, only in the probiotics group (p < 0.001). Conversely, mean urinary indican and 3-MI levels only in the group treated with probiotics (p < 0.001). Compared to placebo group, significant improvements of C-reactive protein (p < 0.001), iron (p < 0.001), ferritin (p < 0.001), transferrin saturation (p < 0.001), β2-microglobulin (p < 0.001), serum iPTH and serum calcium were observed only in the probiotics group. ProbiotiCKD is the first intervention study demonstrating that an intestinal mixed dysbiosis is present even in early CKD stage and can be effectively corrected by the novel mode of administration of high-quality probiotics with improvement of inflammatory indices, iron status and iPTH stabilization.
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