PROBIOTIC SUPPLEMENT VERSUS PLACEBO FOR DECREASE STEATOSIS IN METABOLIC DYSFUNCTION-ASSOCIATED STEATOTIC LIVER DISEASE (MASLD): A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 4
- 主要终点
- Liver steatosis by fibroscan
研究概览
简要总结
Probiotic supplement versus placebo for the treatment of patients with non-alcoholic fatty liver disease: a randomized, double-blind, placebo-controlled trial
详细描述
Probiotic supplement versus placebo for the treatment of patients with non-alcoholic fatty liver disease: a randomized, double-blind, placebo-controlled trial by access liver biochemistry, MRI-PDFF, fibroscan and metabolic profile
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 (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
- 是
入选标准
- •Male and female adults ≥20,<80 years of age who suspected or confirmed diagnosis of NASH/NAFLD suggested by the historical data, they must meet one of the following criteria:
- •Fatty liver by imaging then fibroScan with CAP ≥ 248 dB m Liver biopsy compatible with NASH/NAFLD
排除标准
- •Supplement with probiotic/prebiotic within 2 weeks
- •Previous antibiotic/antifungus within 1 month
- •History of significant alcohol consumption for a period of more than three consecutive months within 1 year before screening. Significant alcohol consumption is defined as equal to or greater than approximately two alcoholic drinks per day for males and approximately 1.5 alcoholic drinks per day for females
- •Regular use of drugs historically associated with NAFLD, which include, but are not limited, to the following: amiodarone, methotrexate, systemic glucocorticoids at greater than 5 mg/d
- •Chronic liver diseases from other cause such as viral hepatitis, autoimmune hepatitis
- •Hepatic decompensation or impairment defined as presence of any of the following:
- •History of esophageal varices, ascites or hepatic encephalopathy.
- •Serum albumin <3.5 g dl-1, except as explained by nonhepatic causes.
- •INR > 1.4
- •Use of GLP-1 agonist therapy (for example, exenatide, liraglutide, lixisenatide, albiglutide, dulaglutide, semaglutide and albiglutide), vitamin E and pioglitazone
- •Active autoimmune disease, including actively treated lupus, rheumatoid arthritis, inflammatory bowel disease
- •Active malignancy on treatment
- •New York Heart Association Class III or IV heart failure or known left ventricular ejection fraction <30%
- •Known immunocompromised status, HIV or who have recurrent or chronic systemic bacterial, fungal, viral or protozoal infections
- •Respiratory compromised
- •Severe renal impairment (eGFR <30 ml/min/1.73 m2)
结局指标
主要结局
Liver steatosis by fibroscan
时间窗: 12 weeks
Shear wave velocity with controlled attenuation parameter (CAP) unit in decibels per meter (dB/m)
Liver steatosis by MRI
时间窗: 12 weeks
Hepatic steatosis with MRI-PDFF (the percent ratio of the density of mobile protons from triglycerides and the total density of protons from mobile triglycerides and mobile water). Outcome Measures was report as percent
Liver stiffness by fibroscan
时间窗: 12 weeks
Fibroscan- transient elastography in kilopascals (kPa)
Liver steatosis by fibroscan
时间窗: 12 weeks
Shear wave velocity with controlled attenuation parameter (CAP) unit in decibels per meter (dB/m)
Liver steatosis by MRI
时间窗: 12 weeks
Hepatic steatosis with MRI-PDFF (the percent ratio of the density of mobile protons from triglycerides and the total density of protons from mobile triglycerides and mobile water). Outcome Measures was report as percent
Liver stiffness by fibroscan
时间窗: 12 weeks
Fibroscan- transient elastography in kilopascals (kPa)
次要结局
- Metabolic profile: serum lipid profiles(12 weeks)
- Metabolic profile(12 weeks)
- Anthropomorphic evaluation(12 weeks)
- Liver inflammation(12 weeks)
- Metabolic profile: HOMA IR(12 weeks)
- Anthropomorphic evaluation: BMI(12 weeks)
- Anthropomorphic evaluation: composition analysis(12 weeks)
- Inflammatory marker(12 weeks)