A Double-blind Randomized Placebo-controlled Study to Evaluate the Effect of Synbiotics SLP07 on Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD-RCT)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Percentage of participants with a reduction of at least 1 grade of steatosis AND/OR >10% reduction in CAP scores at 3 months
研究概览
简要总结
Non-alcoholic fatty liver disease (NAFLD) is one of the most common chronic liver diseases worldwide. Available data indicates that probiotics may regulate the gut microbiota, while Vitamin E and omega 3 are safe and effective at treating NAFLD patients. In this study, investigators aim to investigate if the enhanced synbiotic preparation of SLP07 is efficacious in liver function improvement in subjects with MAFLD.
详细描述
Non-alcoholic fatty liver disease (NAFLD) is one of the most common chronic liver diseases worldwide.(1) The prevalence of NAFLD is estimated to be about 20%-30% in the Western world (2) and increasing in Asia. The prevalence of NAFLD across Asia varies from 5% to 40%.(3,4) The population prevalence of NAFLD in Hong Kong Chinese was 27.3%.(1) NAFLD may progress to non-alcoholic steatohepatitis (NASH), cirrhosis, liver failure and liver cancer, and is believed to be the leading etiology for cryptogenic cirrhosis.(5,6) NAFLD is also strongly associated with obesity and metabolic syndrome and is shown to be an independent cardiovascular risk factor.(7,8) Recently, a consensus by an international panel of experts recommended a change in name for NAFLD to metabolic dysfunction associated with fatty liver disease (MAFLD).(9) Patients who fulfil the MAFLD criteria have more severe metabolic and liver disease than those who fulfil the NAFLD criteria alone. At present, there is no standard pharmacologic therapy available for NAFLD or MAFLD currently.
Recently, it has been reported that NAFLD might be linked to small intestinal bacterial overgrowth (SIBO), which induces liver injury by gut-derived lipopolysaccharides (LPS) and TNF- α production. (10) Probiotics have several anti-inflammatory effects that can contribute to their clinical benefits in NAFLD.(11) Gut microbiota also plays a role in the development of insulin resistance, hepatic steatosis, necroinflammation and fibrosis. (12) The use of probiotics, prebiotics and synbiotics has been considered a potential and promising strategy to regulate the gut microbiota.(13,14) In the meantime, Vitamin E has been recommended for use in NAFLD treatmentand prevents liver injury. Moreover, many clinical trials and meta-analyses have evaluated the efficacy of omega 3 (C20-22 ω3 polyunsaturated fatty acids (PUFA)) in reducing existing NAFLD in adults and children, and the results indicate that omega 3 is safe and effective at lowering liver fat in NAFLD patients. (15,16)
In this study, investigators aim to investigate if the SLP07, which is an investigational product that contains a blend of naturally occurring food-grade Bifidobacterium and Lactobacillus strains, omega-3 and vitamin E, is efficacious in liver function improvement in subjects with MAFLD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
盲法说明
Attending physicians, investigators performing assessments in clinic visits and study participants will be blinded to the group allocation until study completion.
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with MAFLD with CAP ≥ 270 by fibroscan
- •Subjects with diabetes or components of metabolic syndrome
- •Subjects have been taking stable medication 3 months prior to enrolment and are expected to remain stable throughout the study period
- •Written informed consent can be obtained
排除标准
- •Known history of any secondary causes of MAFLD including alcoholic liver disease, drug-induced liver injury, autoimmune hepatitis, viral hepatitis, cholestatic liver disease and metabolic/genetic liver disease
- •Active malignancy (on any kind of treatments for the known cancer)
- •Known diabetes with poor control (HbA1c > 8.5%) within 3 months
- •Significant alcohol consumption (over 10g per day: a half pint or half bottle of beer or a standard-size wine glass)
- •Subjects who are using insulin and Glucagon-like peptide-1(GLP1) such as dulaglutide, semaglutide
- •Consumption of systemic corticosteroids or methotrexate in the last 6 months
- •Use of antibiotics, probiotics or prebiotics one month prior to enrolment
- •Taking any supplements which are claimed to possibly protect the liver or improve liver functions including vitamin E and omega-3
- •Any condition or allergy history for probiotics
- •Any allergy to vitamin E, omega-3 or lactose
结局指标
主要结局
Percentage of participants with a reduction of at least 1 grade of steatosis AND/OR >10% reduction in CAP scores at 3 months
时间窗: 3 months
The change of CAP score measured by fibroscan. CAP score is a measurement of fat accumulation in the liver to further determine the steatosis grade. The CAP score ranges from 100 to 400 decibels per meter (dB/m). The higher the score, the more the steatosis is.
次要结局
- Percentage of participants with improvement in steatohepatitis across the study period.(3 months)
- Changes in faecal microbial profiling across 16 weeks(3 months)
- Change in lipid profile across the study period.(3 months)
- Change of body mass index (BMI) across the study period.(3 months)
- Change of body waist circumference across the study period.(3 months)
- Adverse events reported during the study period.(3 months)
- Change of CAP score across the study period(3 months)
- Change of liver stiffness (measured in kPa) across the study period(3 months)