Guida B, Germanò R, Trio R, Russo D, Memoli B, Grumetto L, Barbato F, Cataldi M
Division of Physiology, Department of Clinical Medicine and Surgery, Federico II University of Naples, Italy.
Division of Physiology, Department of Clinical Medicine and Surgery, Federico II University of Naples, Italy.
Nutr Metab Cardiovasc Dis. 2014 Sep;24(9):1043-9. doi: 10.1016/j.numecd.2014.04.007. Epub 2014 May 2.
In patients with chronic kidney disease (CKD), alterations in gut microbiome are posited to be responsible for gastrointestinal symptoms and generation of p-cresol, a uremic toxin that has been associated with CKD progression and cardiovascular mortality. This pilot study investigated whether Probinul-neutro®, a synbiotic that normalizes intestinal microflora, may lower plasma p-cresol concentrations and reduce gastrointestinal symptoms in non-dialyzed CKD patients.
This was a double-blind, randomized placebo-controlled trial. Thirty patients on 3-4 CKD stages were randomized to receive either Probinul neutro® or placebo for 4 weeks. Total plasma p-cresol concentration was assessed at baseline, and 15 and 30 days after treatment start. At the same study times, ease and frequency of defecation, upper and lower abdominal pain, stool shape, borborygmi, and flatus were quantified by subjective assessment questionnaires. Compared to baseline total plasma p-cresol median concentrations on 15th and 30th day were significantly lower in patients receiving Probinul-neutro® (2.31 and 0.78 vs. 3.05 μg/ml, p < 0.05; n = 18); no changes of plasma p-cresol concentrations were recorded in placebo-treated patients. No significant changes in gastrointestinal symptoms were observed during the study both in Probinul-neutro®-treated and placebo-treated patients.
Probinul-neutro® lowered total plasma p-cresol concentrations but did not ameliorate gastrointestinal symptoms in non-dialyzed CKD patients. Because high plasma concentrations of p-cresol in early phases of CKD are predictive of progression to end-stage renal disease, the results of our study suggest that synbiotics deserve attention as possible tools to delay CKD progression towards end-stage renal disease (ESRD).
NCT02008331.
在慢性肾脏病（CKD）患者中，肠道微生物群的改变被认为是胃肠道症状以及对甲酚产生的原因，对甲酚是一种尿毒症毒素，与CKD进展和心血管死亡率相关。这项初步研究调查了一种能使肠道微生物群正常化的合生元制剂Probinul-neutro®是否可降低非透析CKD患者的血浆对甲酚浓度并减轻胃肠道症状。
这是一项双盲、随机、安慰剂对照试验。30例处于3-4期CKD的患者被随机分为两组，分别接受Probinul neutro®或安慰剂治疗4周。在基线期、治疗开始后15天和30天评估血浆对甲酚总浓度。在相同的研究时间，通过主观评估问卷对排便的难易程度和频率、上腹部和下腹部疼痛、粪便形状、肠鸣音和肠胃气胀进行量化。与基线相比，接受Probinul-neutro®治疗的患者在第15天和第30天的血浆对甲酚中位数浓度显著降低（分别为2.31和0.78 vs. 3.05 μg/ml，p<0.05；n = 18）；接受安慰剂治疗的患者血浆对甲酚浓度无变化。在研究期间，接受Probinul-neutro®治疗和接受安慰剂治疗的患者胃肠道症状均未观察到显著变化。
Probinul-neutro®降低了非透析CKD患者的血浆对甲酚总浓度，但未改善胃肠道症状。由于CKD早期血浆对甲酚高浓度可预测进展至终末期肾病，我们的研究结果表明，合生元作为延缓CKD进展至终末期肾病（ESRD）的可能工具值得关注。
NCT02008331。
