The Effect of Helicobacter Pylori Eradication on Liver Fat Content in Subjects With Non-alcoholic Fatty Liver Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change from baseline liver fat content at 6 months
研究概览
简要总结
The role of Helicobacter pylori(HP)in the pathogenesis of non-alcoholic fatty liver disease (NAFLD) is controversial.
详细描述
This randomized double blind clinical trial was performed in dyspeptic patients with positive antibody to HP and the evidence of fatty liver in ultrasonography. After excluding other causes, participants with persistent elevated serum aminotransferase levels were presumed to have NAFLD. Those with NAFLD liver fat score greater than (-0.64) and positive urea breath test (UBT) were enrolled. They were randomly assigned to lifestyle modification alone or lifestyle modification plus HP eradication groups. Quadruple therapy (omeprazole, amoxicillin, bismuth subcitrate, and clarithromycin) for HP eradication was performed in two weeks. HP eradication was documented by UBT. Liver fat content, fasting serum glucose, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, triglyceride, cholesterol, high and low-density lipoprotein,homeostasis model assessment-insulin resistance(HOMA-IR), and anthropometric measurements (body mass index and waist circumference) were checked at baseline and six months later.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •dyspeptic patients with positive antibody to H.pylori and
- •persistent elevated aminotransferase levels with the evidence of fatty liver in ultrasonography, who were referred to a gastroenterology clinic.
排除标准
- •alcohol use (more than 20 gram per day in men and 10 gram per day in women per day),
- •heart disease (ischemic or congestive),
- •hepatic disease (viral hepatitis, autoimmune hepatitis, wilson disease, hemochromatosis, liver mass lesion),
- •renal disease (serum creatinine concentration of > 1.5 mg/dl),
- •any severe systemic co-morbidities, neoplasm,
- •using any hepatotoxic medication during the past 3 months,
- •previous history of peptic ulcer,
- •previous history of H.pylori eradication,
- •existence of alarm signs (weight loss, dysphagia, anemia, vomiting, positive family history of gastrointestinal cancers), and
- •pregnant or lactating women.
研究组 & 干预措施
H.pylori eradication
H.pylori eradication by quadruple antibiotic therapy for two weeks plus obtaining ideal body weight by calorie restriction diet and programmed physical activity.
干预措施: H.pylori eradication (Omeprazole, Amoxicillin, Bismuth subcitrate, Azithromycin) (Drug)
结局指标
主要结局
Change from baseline liver fat content at 6 months
时间窗: 6 months
次要结局
- Change from baseline liver function tests at 6 months(6 months)
研究者
Raika Jamali, MD
Assistant Professor of Medicine
Tehran University of Medical Sciences