Department of Family Medicine, Faculty of Medicine, Ain Shams University, Cairo, Egypt.
Gastroenterology and Hepatology, Internal Medicine Department, Ain Shams University, Cairo, Egypt.
BMC Gastroenterol. 2024 Oct 8;24(1):354. doi: 10.1186/s12876-024-03424-3.
Non-alcoholic fatty liver disease (NAFLD) is characterized by hepatic fat accumulation (> 5% of liver tissue) in the absence of alcohol abuse or other chronic liver diseases. NAFLD can progress to non-alcoholic steatohepatitis (NASH), fibrosis, cirrhosis, and hepatocellular carcinoma (HCC). This study aimed to assess the efficacy of probiotic (lactobacillus) supplementation on NAFLD fibrosis score.
A double-arm randomized controlled trial was conducted in the family medicine clinic of a tertiary hospital, enrolling patients with sonographic evidence of NAFLD. Fifty patients were divided into two groups: the Probiotic group received lifestyle modification instructions along with daily probiotic supplementation for twelve weeks, with regular monthly follow-up visits. The Standard Treatment group received low-fat diet and lifestyle modification instructions only.
The mean age of participants was 46.10 years (SD 10.11), with 70% females and 30% males. The study found a statistically significant difference in liver enzymes (ALT and AST) and BMI in the probiotic group before and after intervention. However, there was no significant difference in NAFLD fibrosis score between the two groups.
Short-term probiotic treatment resulted in improvements in ALT, AST, and BMI in the probiotic group, but did not significantly affect NAFLD fibrosis score. Further research with larger sample sizes and longer follow-up periods is warranted.
The clinical trial was registered at Protocol Registration and Results System with number NCT06074094 (12/09/2021).
非酒精性脂肪性肝病（NAFLD）的特征是肝脏脂肪堆积（肝组织中>5%的脂肪），不存在酒精滥用或其他慢性肝病。NAFLD 可进展为非酒精性脂肪性肝炎（NASH）、纤维化、肝硬化和肝细胞癌（HCC）。本研究旨在评估益生菌（乳杆菌）补充对非酒精性脂肪性肝病纤维化评分的疗效。
在一家三级医院的家庭医学诊所进行了一项双臂随机对照试验，招募了超声检查有 NAFLD 证据的患者。50 名患者被分为两组：益生菌组在接受 12 周的生活方式改变指导和每日益生菌补充的同时，每月定期随访。标准治疗组仅接受低脂饮食和生活方式改变指导。
参与者的平均年龄为 46.10 岁（SD 10.11），女性占 70%，男性占 30%。研究发现，益生菌组干预前后肝酶（ALT 和 AST）和 BMI 存在统计学显著差异。然而，两组间的非酒精性脂肪性肝病纤维化评分无显著差异。
短期益生菌治疗可改善益生菌组的 ALT、AST 和 BMI，但对非酒精性脂肪性肝病纤维化评分无显著影响。需要进行更大样本量和更长随访期的进一步研究。
该临床试验在方案注册和结果系统中以 NCT06074094 号注册（2021 年 12 月 9 日）。
