Effect of Probiotic Supplementation on Non-alcoholic Fatty Liver Disease in Patients Attending Family Medicine Clinic in Ain Shams University Hospitals
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- non alcoholic fatty liver disease (NAFLD) fibrosis score
研究概览
简要总结
this study aimed to evaluate the effectiveness of Probiotics supplementation (lactobacillus) on NAFLD fibrosis score.
详细描述
Non-alcoholic fatty liver disease (NAFLD) is a disease characterized by accumulation of fat (> 5% of the liver tissue), in the absence of alcohol abuse or other chronic liver diseases. NAFLD can cause liver inflammation and progress to non-alcoholic steatohepatitis (NASH), fibrosis, cirrhosis or hepatocellular carcinoma (HCC).
The global prevalence of NAFLD in adults is estimated to be approximately 25%.The prevalence of NAFLD increases with increasing body mass index. in 2012 Chalasani et al, reported that 67% of overweight and 94% of obese individuals have NAFLD.
There is a consensus regarding increasing worldwide prevalence of NAFLD and its impact on health, especially the progression to liver cirrhosis and hepatocellular carcinoma. Longitudinal studies of NAFLD have reported an increase in all-cause mortality, cardiovascular mortality, and liver-related mortality , NAFLD carries a large economic burden and therefore poor health-related quality of life.
Lifestyle changes (diet and exercise) are the major and first suggestions of the guidelines ,as regard pharmaceutical interventions, agents with potential benefit in NASH include thiazolidinediones (TZDs), statins although they are well recognized in the treatment of dyslipidemia, their use as a specific treatment for NAFLD is not well evidenced.
There is some data suggest that disruptions in the gut microbiome may play a role in the pathogenesis of NAFLD and progressions to NASH.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between18 and 60
- •BMI ≥ 25 kg/m2
- •Sonographic findings of NAFLD +/- elevated liver enzymes (not more than 2 folds increase).
排除标准
- •▪ Any evidence of chronic liver diseases including viral hepatitis (B and C), auto immune hepatitis.
- •History of alcohol drinking.
- •Chronic medication use (drugs that cause elevated liver enzymes, recent antibiotic use or paracetamol use in the last month)
- •Persistent elevation of liver enzymes for 3 months.
- •History of DM.
- •History of statin therapy for cardiovascular disease (CVD).
- •History of recent operation.
- •History of gastroenteritis or diarrhea in the last 2 week.
研究组 & 干预措施
probiotic group
Healthy lifestyle habits and standard diet was recommended for participants ,Probiotic supplementation (Lacteol fort 10 billion) which contains culture medium and lactobacillus LS as active ingredients was administered in the form of oral sachets once daily for 12 weeks.
干预措施: Control Test (Drug)
standard treatment group
Healthy lifestyle habits and standard diet was recommended for participants ,
干预措施: Control Test (Drug)
结局指标
主要结局
non alcoholic fatty liver disease (NAFLD) fibrosis score
时间窗: 12 week of probiotic supplementation
NAFLD fibrosis score constructed from routine clinical and laboratory variables can accurately predict the presence or absence of advanced fibrosis in NAFLD This scoring system had an area under the ROC curve of 0.88 (95% CI 0.85-0.92). 2 cutoff points were selected to identify the presence (\> 0.676) and absence (\< -1.455) of significant fibrosis.
次要结局
- ALT , AST(12 week of probiotic supplementation)
- body mass index (BMI)(12 week of probiotic supplementation)