Department of Nutrition, Medical School, Mashhad University of Medical Sciences, Mashhad, Iran.
Metabolic Syndrome Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.
Trials. 2020 Feb 24;21(1):221. doi: 10.1186/s13063-020-4136-3.
An extreme and persistent dysbiosis occurs among critically ill patients, regardless of the heterogeneity of disease. Dysbiosis in critically ill patients may make them prone to hospital-acquired infections, sepsis, multi-organ failure (MOF), energy homeostasis disturbance, muscle wasting, and cachexia. Modulation of gut microbiota through synbiotics can be considered as a potential treatment for muscle wasting and macronutrient homeostasis disturbances.
This is a prospective, single-center, double-blind, parallel randomized controlled trial with the aim to evaluate the effects of synbiotic supplementation on energy and macronutrient homeostasis and muscle wasting in critically ill patients. A total of 40 hemodynamically stable, adult, critically ill patients who receive enteral nutrition via a nasogasteric tube (NGT) in the 24-48 h after admission to critical care will be included in this study. Eligible patients will be randomly assigned to receive Lactocare (ZistTakhmir) capsules 500 mg every 12 h or a placebo capsule, which contains only the sterile maize starch and is similar to synbiotic capsules for 14 days. The synbiotic and placebo capsules will be given through the nasogastric tube, separately from gavage, after feeding.
Gut microbiota modulation through synbiotics is proposed to improve clinical prognosis and reduce infectious complications, ventilator dependency, and length of ICU stay by improving energy and macronutrient homeostasis and reducing muscle protein catabolism.
Iranian Registry of Clinical Trials, IRCT20190227042857N1. Registered on 17 March 2019.
危重症患者无论疾病异质性如何,都会出现极端且持久的肠道菌群失调。危重症患者的肠道菌群失调可使他们易患医院获得性感染、败血症、多器官衰竭 (MOF)、能量平衡紊乱、肌肉消耗和恶病质。通过合生元来调节肠道微生物群可被视为治疗肌肉消耗和宏量营养素平衡紊乱的一种潜在方法。
这是一项前瞻性、单中心、双盲、平行随机对照试验,旨在评估合生元补充对危重症患者能量和宏量营养素平衡及肌肉消耗的影响。本研究共纳入 40 例血流动力学稳定的成年危重症患者,这些患者在入住重症监护病房后 24-48 小时内通过鼻胃管 (NGT) 接受肠内营养。符合条件的患者将被随机分配接受 Lactocare (ZistTakhmir) 胶囊 500mg,每 12 小时一次,或安慰剂胶囊,安慰剂胶囊仅含无菌玉米淀粉,与合生元胶囊相似,疗程为 14 天。合生元和安慰剂胶囊将在喂养后通过鼻胃管分别与管饲分开给予。
通过合生元调节肠道微生物群被提议通过改善能量和宏量营养素平衡,减少肌肉蛋白分解,来改善临床预后并减少感染性并发症、呼吸机依赖和 ICU 住院时间。
伊朗临床试验注册中心,IRCT20190227042857N1。注册于 2019 年 3 月 17 日。