The Effects of Synbiotics Supplement on Lipid Profile, Liver Enzymes, Inflammatory Factors and Hepatic Fibrosis in Patients With Nonalcoholic Steatohepatitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 主要终点
- Alaninaminotransferase (ALT)
研究概览
简要总结
To study the effects of synbiotics supplement on lipid profile, liver enzymes, inflammatory factors and hepatic fibrosis in patients with Nonalcoholic Steatohepatitis (NASH), 50 patients who referred to Gastrointestinal (GI) clinic with steatosis grade 1 or more will be randomly allocated to receive 2 protexin capsules or placebos for 7 months; both groups will be advised to adherence our diet and exercise program too. At the first and the end of the intervention, lipid profiles, liver enzymes, some inflammatory cytokines, and liver fibrosis will be assessed and compared between groups.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of 18 to 70 years
- •Body Mass Index (BMI) between 25-40
- •Serum alaninaminotransferase more than 1.5 fold of upper limit of normal range
- •Sonographic findings compatible with hepatic steatosis (degree 2 or more)
排除标准
- •Taking any kind of antibiotics two weeks before recruitment
- •History of alcohol consumption
- •pregnancy or lactation
- •Professional athletes
- •Other liver disease (viral/etc)
- •Use of drugs such as calcium channel blockers, high dose synthetic estrogens, methotrexate , amiodarone, steroids, chloroquine, immunosuppressive drugs, lipid-lowering agents, metformin and vitamin E
- •A history of Hypertension, Cardiovascular disease, Pulmonary disease, Renal disease & Celiac disease; Cirrhosis
- •History of Upper GI surgery / Prior surgical procedures such as jejunoileal or jejunocolic bypass, gastroplasty
- •Following program to lose weight in recent 3 mo
- •A history of hypothyroidism or Cushing's syndrome
结局指标
主要结局
Alaninaminotransferase (ALT)
时间窗: 28 weeks
Liver fibrosis
时间窗: 28 weeks
次要结局
- Body Mass Index (BMI)(28 weeks)
研究者
Dr Azita Hekmatdoost
Principal Investigator
National Nutrition and Food Technology Institute