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对创新型合生元制剂用于IIIb-IV期慢性肾病患者的评估。

evaluation of an innovative synbiotics on stage IIIb-IV chronic kidney disease patients.

作者信息

Vacca Mirco, Celano Giuseppe, Calabrese Francesco Maria, Rocchetti Maria Teresa, Iacobellis Ilaria, Serale Nadia, Calasso Maria, Gesualdo Loreto, De Angelis Maria

机构信息

Department of Soil Plant and Food Sciences, University of Bari, Bari, Italy.

Department of Clinical and Experimental Medicine, University of Foggia, Foggia, Italy.

出版信息

Front Nutr. 2023 Jun 15;10:1215836. doi: 10.3389/fnut.2023.1215836. eCollection 2023.

DOI:10.3389/fnut.2023.1215836
PMID:37396126
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10311028/
Abstract

BACKGROUND

Microbiota unbalance has been proven to affect chronic kidney disease (CKD) patients and, noteworthy, microbiota composition and activity are implicated in CKD worsening. The progression of kidney failure implies an exceeding accumulation of waste compounds deriving from the nitrogenous metabolism in the intestinal milieu. Therefore, in the presence of an altered intestinal permeability, gut-derived uremic toxins, i.e., indoxyl sulfate (IS) and p-cresyl sulfate (PCS), can accumulate in the blood.

METHODS

In a scenario facing the nutritional management as adjuvant therapy, the present study assessed the effectiveness of an innovative synbiotics for its ability to modulate the patient gut microbiota and metabolome by setting a randomized, single-blind, placebo-controlled, pilot trial accounting for IIIb-IV stage CKD patients and healthy controls. Metataxonomic fecal microbiota and fecal volatilome were analyzed at the run-in, after 2 months of treatment, and after 1 month of wash out.

RESULTS

Significant changes in microbiota profile, as well as an increase of the saccharolytic metabolism, in feces were found for those CKD patients that were allocated in the synbiotics arm.

CONCLUSIONS

Noteworthy, the here analyzed data emphasized a selective efficacy of the present synbiotics on a stage IIIb-IV CKD patients. Nonetheless, a further validation of this trial accounting for an increased patient number should be considered.

CLINICAL TRIAL REGISTRATION

https://clinicaltrials.gov/, identifier NCT03815786.

摘要

背景

微生物群失衡已被证明会影响慢性肾脏病(CKD)患者,值得注意的是,微生物群的组成和活性与CKD的恶化有关。肾衰竭的进展意味着肠道环境中含氮代谢产生的废物化合物过度积累。因此,在肠道通透性改变的情况下,肠道来源的尿毒症毒素,即硫酸吲哚酚(IS)和对甲酚硫酸盐(PCS),会在血液中积累。

方法

在将营养管理作为辅助治疗的情况下,本研究通过开展一项针对IIIb-IV期CKD患者和健康对照的随机、单盲、安慰剂对照的试点试验,评估了一种创新型合生元调节患者肠道微生物群和代谢组的能力。在导入期、治疗2个月后以及洗脱1个月后,对宏分类粪便微生物群和粪便挥发性代谢物进行了分析。

结果

在分配到合生元组的CKD患者的粪便中,发现微生物群谱有显著变化,以及糖酵解代谢增加。

结论

值得注意的是,此处分析的数据强调了本合生元对IIIb-IV期CKD患者具有选择性疗效。尽管如此,应考虑进一步验证该试验,纳入更多患者。

临床试验注册

https://clinicaltrials.gov/,标识符NCT03815786。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4ea1/10311028/24bd56a2708a/fnut-10-1215836-g006.jpg
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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4ea1/10311028/24bd56a2708a/fnut-10-1215836-g006.jpg
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