To Evaluate the Clinical Efficacy of Probiotic in Patients With NAFLD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Serum ALT (Alanine Aminotransferase) level at baseline
研究概览
简要总结
In this study, the improvement of the clinical status of early-stage non-alcoholic fatty liver disease (NAFLD) patients after the probiotic intervention will be assessed. And the mechanism of probiotics to prevent the progression of illness would be investigated. The chronic inflammation status, systemic oxidative stress, metabolism of carbohydrates and lipid, and gut microbiota of NAFLD patients will also be analyzed.
详细描述
Uncontrolled NAFLD evolves in Non-Alcoholic SteatoHepatitis (NASH), cirrhosis and liver cancer. Early intervention to prevent the progression of illness of NAFLD is very important. From 2005 to 2018, 15 clinical trials concluded that multiple-strain probiotics significantly reduced the liver inflammation index and blood lipids in NAFLD patients. Many reports indicated that NAFLD-associated risk factors, such as chronic inflammation, oxidative stress, insulin resistance, dyslipidemia, and obesity are closely correlated with gut microbiota. Some substances (such as endotoxin and alcohol) produced by harmful gut bacteria caused the progression of the illness of NAFLD.
Three strains are Genmont® Normal Lactobacillus (GMNL) which were divided from natural environments, included Lactobacillus reuteri GMNL-263 (heat-killed) and GMNL-89 (alive) and Lactobacillus rhamnosus GMNL-74 ( alive). They are all isolated from the gastrointestinal tract of healthy Taiwanese and were known as common food material worldwide. The previous clinical research on probiotic consumption in type 2 Diabetes mellitus patients under normal drug treatment was conducted in Changhua Christian Hospital. Results showed that L. reuteri GMNL-263 was able to stabilize the weight and blood pressure of patients. L. reuteri GMNL-89 had a stable effect on glycated hemoglobin. There was no adverse reaction when probiotics combining with type 2 diabetes drugs. Meanwhile, L. rhamnosus GMNL-74 was observed to reduce weight gain in obese mice. In this clinical study, The anti-liver inflammation effect of consumption of Lactobacillus sachet in NAFLD patients will be demonstrated at baseline, 3 months and 6 months. In this clinical study, the anti-liver inflammation effect of consumption of Lactobacillus sachet in NAFLD patients will be demonstrated at baseline, 3 months and 6 months to understand the impact of the probiotics on NAFLD. Since the treatment of fatty liver should focus on controlling weight, blood sugar, and blood fat, the relevant clinical indexes will also be investigated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Nonalcoholic fatty liver disease (NALFD) by ultrasound.
- •The range of Alanine aminotransferase (ALT) blood test is 60-300 U/L
排除标准
- •Alcoholic consumption (Female ≥ 10g/day or Male ≥ 20g/per)
- •Patients with liver diseases, HBV(hepatitis B virus), HCV(hepatitis C virus), Primary Biliary Cholangitis.
- •Autoimmune system disease
- •Wilson's disease
- •Hereditary hemochromatosis
- •Patients with uncontrolled malignancy
- •The subject had previously received weight reduction surgery
- •Taking Antibiotics, probiotics, or any other drugs that affect NAFLD or glucose and lipid metabolism in past 2 months
- •Pregnant or lactating female patients
- •Patient who have severe allergy to soybeans or peanuts
结局指标
主要结局
Serum ALT (Alanine Aminotransferase) level at baseline
时间窗: baseline
The number of patients will be enrolled with the concentration of ALT (Alanine Aminotransferase) ranging from 60 to 300 U/mL in serum.
Change from baseline in Serum ALT (Alanine Aminotransferase) level at 3-months
时间窗: 3-months
Fasting blood samples will be collected to examine the variation of ALT (Alanine Aminotransferase).
Change from baseline in Serum ALT (Alanine Aminotransferase) level at 6-months
时间窗: 6-months
Fasting blood samples will be collected to examine the variation of ALT (Alanine Aminotransferase).
次要结局
- Change from baseline in BMI (Body Mass index) at 3-months(3-months)
- Change from baseline in BMI (Body Mass index) at 6-months(6-months)
- Change from baseline in Waist and hip circumference at 3-months(3-months)
- Change from baseline in Waist and hip circumference at 6-months(6-months)
- Change from baseline in blood pressure at 3-months(3-months)
- Change from baseline in blood pressure at 6-months(6-months)
- Change from baseline in the progress of the non-alcoholic fatty liver disease at 3-months(3-months)
- Change from baseline in the progress of the non-alcoholic fatty liver disease at 6-months(6-months)
- Change from baseline in levels of AST(Aspartate Aminotransferase) at 3-months(3-months)
- Change from baseline in levels of AST(Aspartate Aminotransferase) at 6-months(6-months)
- Change from baseline in the level of γ-GT (γ-Glutamyl Transpeptidase) at 3-months(3-months)
- Change from baseline in the level of γ-GT (γ-Glutamyl Transpeptidase) at 6-months(6-months)
- Change from baseline in levels of serum insulin at baseline(3-months)
- Change from Baseline in levels of HOMA-IR (Homeostatic Model Assessment for Insulin Resistance) at 3-months(3-months)
- Change from baseline in levels of TC (Total Cholesterol) at 3-months(3-months)
- Change from baseline in levels of TC (Total Cholesterol) at 6-months(6-months)
- Change from baseline in level of LDL (Low density lipoprotein) at 6-months(6-months)
- Change from baseline in level of HDL (High density lipoprotein) at 3-months(3-months)
- Change from baseline in level of IL-6 (Interleukin-6) at 6-months(6-months)
- Change from baseline in level of TG (Triglyceride) at 3-months(3-months)
- Change from baseline in the level of BUN (Blood Urea Nitrogen) at 3-months(3-months)
- Change from baseline in the level of BUN (Blood Urea Nitrogen) at 6-months(6-months)
- Change from baseline in the level of CRE (Creatinine) at 3-months(3-months)
- Change from baseline in the level of CRE (Creatinine) at 6-months(6-months)
- Change from baseline in the level of FBS (Fasting Blood Sugar) at 6-months(6-months)
- Change from baseline in levels of HbA1c (Hemoglobin A1C) at 6-months(6-months)
- Change from baseline in level of TG (Triglyceride) at 6-months(6-months)
- Change from baseline in level of TNF-α (Tumor necrosis factor-α) at 3-months(3-months)
- Change from baseline in levels of HbA1c (Hemoglobin A1C) at 3-months(3-months)
- Change from 3-months in levels of serum insulin at baseline(6-months)
- Change from baseline in levels of HOMA-IR (Homeostatic Model Assessment for Insulin Resistance) at 6-months(6-months)
- Change from baseline in level of HDL (High density lipoprotein) at 6-months(6-months)
- Change from baseline in level of LDL (Low density lipoprotein) at 3-months(3-months)
- Change from baseline in level of hs-CRP (high-sensitivity C-reactive protein) at 3-months(3-months)
- Change from baseline in level of TNF-α (Tumor necrosis factor-α) at 6-months(6-months)
- Change from baseline in level of IL-1β (Interleukin-1 β) at 6-months(6-months)
- Change from baseline in level of IL-6 (Interleukin-6) at 3-months(3-months)
- Change from baseline in level of LPS (Lipopolysaccharides) at 6-months(6-months)
- Change from baseline in level of Leptin at 6-months(6-months)
- Change from baseline in the level of SCFA (Short Chain Fatty Acids) at 6-months(6-months)
- Change from baseline in the level of TMAO (Trimethylamine N-oxide) at 6-months(6-months)
- Change from baseline in Self-questionnaire of Diet and lifestyle assessments at 6-months(6-months)
- Change from baseline in gut microbiota at 6-months(6-months)
- Change from baseline in level of hs-CRP (high-sensitivity C-reactive protein) at 6-months(6-months)
- Change from baseline in level of IL-1β (Interleukin-1 β) at 3-months(3-months)
- Change from baseline in level of LPS (Lipopolysaccharides) at 3-months(3-months)
- Change from baseline in level of Leptin at 3-months(3-months)
- Change from baseline in level of Adiponectin at 3-months(3-months)
- Change from baseline in level of Adiponectin at 6-months(6-months)
- Change from baseline in self-record of the International physical activity questionary (IPAQ) in physical assessment at 6-months(6-months)
- Change from baseline in levels of FBS (Fasting Blood Sugar) at 3-months(3-months)