Clinical Nutrition Unit, National Institute of Health and Science on Aging, IRCCS INRCA Ancona, Via della Montagnola 81, 60127 Ancona, Italy.
Probiotical Research Srl, Via E.Mattei 3, 28100 Novara, Italy.
Nutrients. 2021 Jan 27;13(2):391. doi: 10.3390/nu13020391.
A double-blind, placebo-controlled study was performed in a sample of geriatric patients treated with home enteral nutrition (HEN) to analyze the efficacy of a probiotic supplement Proxian, which contains LP01 (LMG P-21021), Lb26 (DSM 16341), subsp. BS01 (LMG P-21384), and is enriched with zinc (Zn) and selenium (Se), in reducing the incidence of infections and modulating inflammation. Thirty-two subjects were enrolled (mean age 79.7 ± 10.3 years), 16 in the intervention group, 16 controls. They received Proxian or placebo for 60 days. Patients were assessed at baseline (t) and 60 (t) and 90 (t) days after the beginning. Infections were detected by information regarding their clinical manifestations and the incidence of antibiotic therapy. Levels of C-reactive protein (CRP) were measured to study inflammation. Information on bowel function, nutritional status and testimonials regarding the feasibility of administration of the product were collected. Differences between the two groups in number of infections (25% intervention group vs. 44% controls), antibiotic therapies (12% vs. 37%) and modulation of CRP levels (median CRP moved from 0.95 mg/L (t) to 0.6 (t) and 0.7 (t) in intervention group vs. 0.7 mg/L, 0.5 and 0.7 in controls) did not reach statistical significance. No significant changes in bowel function and nutritional status were found. Caregivers' adherence was 100%. Results of this "IntegPRO" study showed that Proxian is potentially safe, easy to administer and promising for further studies but it appears not to change the incidence of infections or modulate inflammation in elderly treated with HEN. The utility of Proxian in reducing the incidence of infections and modulating inflammation in these subjects needs to be investigated by a larger multi-center clinical trial, and by using additional analyses on inflammatory markers and markers of infections.
一项针对接受家庭肠内营养（HEN）治疗的老年患者的双盲、安慰剂对照研究，旨在分析益生菌补充剂 Proxian 的疗效。该补充剂含有 LP01（LMG P-21021）、Lb26（DSM 16341）、亚种 BS01（LMG P-21384），并富含锌（Zn）和硒（Se），用于降低感染发生率和调节炎症。共纳入 32 名受试者（平均年龄 79.7 ± 10.3 岁），16 名干预组，16 名对照组。他们接受 Proxian 或安慰剂治疗 60 天。患者在基线（t）和开始后 60（t）和 90（t）天进行评估。通过有关临床表现和抗生素治疗的发生率来检测感染。测量 C 反应蛋白（CRP）水平以研究炎症。收集有关肠道功能、营养状况和产品给药可行性的证明信息。感染人数（干预组 25%，对照组 44%）、抗生素治疗（12% vs. 37%）和 CRP 水平的调节（干预组 CRP 中位数从 0.95 mg/L（t）降至 0.6（t）和 0.7（t），对照组为 0.7 mg/L，0.5 和 0.7）两组之间差异无统计学意义。未发现肠道功能和营养状况有明显变化。护理人员的依从性为 100%。“IntegPRO”研究的结果表明，Proxian 具有潜在的安全性，易于管理，有进一步研究的前景，但似乎不能改变接受 HEN 治疗的老年人的感染发生率或调节炎症。需要更大规模的多中心临床试验和对炎症标志物和感染标志物的额外分析来研究 Proxian 在降低这些受试者感染发生率和调节炎症方面的作用。
