The Effects of Synbiotics on the Liver Steatosis, Inflammation, and Gut Microbiome of Non-alcoholic Fatty Liver Disease Patients- Randomized trial

Background: Non-alcoholic fatty liver disease (NAFLD) represents a spectrum of pathological conditions from simple fat accumulation to non-alcoholic steatohepatitis. The possible role of the intestinal microbiome on NAFLD development has recently been in focus. Our study aimed to examine the effects of synbiotic administration on the liver steatosis, lipid metabolism, inflammation, and stool microbiome composition.
Materials and methods: A double-blind, placebo-controlled study was conducted involving 84 patients with NAFLD, defined by the following criteria - an elastometric attenuation coefficient (ATT) greater than 0.63 dB/cm/MHz with an alanine aminotransferase level above 40 U/L for men and 35 U/L for women. The patients were divided into an intervention group treated with a synbiotic with 64x109 CFU of Lactobacillus and Bifidobacterium and 6g of inulin and a control group treated with a placebo.
Results: Using synbiotics for 12 weeks significantly decreased liver steatosis (ΔATT -0.006±0.023 vs -0.016±0.021 dB/cm/MHz, p=0.046). The group of patients treated with the synbiotic showed a statistically significant decrease in the level of high-sensitive C-reactive protein (hs-CRP) (Δhs-CRP 0 vs -0.7 mg/L, p≤0.001). Synbiotics significantly enriched the microbiome of patients in the intervention group with the genera Lactobacillus, Bifidobacterium, Faecalibacterium, and Streptococcus, by 81%, 55%, 51%, and 40%, respectively, with a reduction of Ruminococcus and Enterobacterium by 35% and 40%. Synbiotic treatment significantly shortened the gut transition time (ΔGTT -5h vs. -10h, p=0.031).
Conclusion: Synbiotics could be an effective, safe, and affordable option that could be important in NAFLD treatment.

背景：非酒精性脂肪性肝病（NAFLD）是一系列病理状态的统称，从单纯的脂肪积累到非酒精性脂肪性肝炎。近年来，肠道菌群在NAFLD发病机制中的潜在作用受到了广泛关注。本研究旨在探讨益生菌联合益生元对肝脏脂肪变性、脂质代谢、炎症反应及粪便微生物群组成的调控作用。
材料与方法：本研究采用双盲、安慰剂对照试验，纳入84例NAFLD患者，根据以下标准进行定义：男性丙氨酸转氨酶（ALT）水平高于40 U/L，女性高于35 U/L，以及弹性衰减系数（ATT）大于0.63 dB/cm/MHz。患者被随机分为干预组和对照组，干预组接受含有64x10^9 CFU的乳酸杆菌和双歧杆菌以及6g低聚果糖的益生菌联合益生元治疗，对照组接受安慰剂治疗。
结果：经过12周益生菌联合益生元治疗，显著降低了肝脏脂肪变性（ΔATT -0.006±0.023 vs -0.016±0.021 dB/cm/MHz，p=0.046）。接受益生菌联合益生元治疗的患者，其高敏C反应蛋白（hs-CRP）水平显著降低（Δhs-CRP 0 vs -0.7 mg/L，p≤0.001）。益生菌联合益生元治疗显著增加了干预组患者肠道中乳杆菌、双歧杆菌、粪杆菌和链球菌等属的微生物群丰度，分别增加了81%、55%、51%和40%，同时显著降低了瘤胃球菌和肠杆菌属的丰度，分别降低了35%和40%。益生菌联合益生元治疗显著缩短了肠道转运时间（ΔGTT -5h vs. -10h，p=0.031）。
结论：益生菌联合益生元可能成为治疗NAFLD的有效、安全且经济实惠的方案。