Gut Microbiota Profile Analysis and Randomized Controlled Trials (RCT) Study of the Effect of Synbiotics on Insulin and TNF-α in Metabolic Dysfunction -Associated Fatty Liver Disease (MAFLD)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Complete Hematology
研究概览
简要总结
Primary Objective: To analyze the effect of synbiotic supplementation on metabolic profile, insulin and TNF-α and gut microbiota changes in patients with Metabolic dysfunction-Associated Fatty Liver Disease (MAFLD).
Research question: Are there any changes in metabolic profile, Insulin and TNF-α and gut microbiota changes in MAFLD patients after synbiotic supplementation
Participants will:
- Treatment group given supplementation and the control group will be given placebo at a dose of 2x1 tablet for 12 weeks.
- Patients will visit the hospital every 28 days for up to 4 months for control and follow-up supplementation.
- patients will be given a supplement consumption compliance logbook and a food record logbook used to record food consumption filled in by the patient.
详细描述
Non-alcoholic Fatty Liver Disease (NAFLD) is a common chronic liver disease estimated to affect 25% of the global population. NAFLD is defined as the presence of fat in the liver that is not associated with alcohol consumption. The researchers proposed a new term, Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD), which covers a range of liver conditions associated with metabolic dysregulation, including obesity and type 2 diabetes. MAFLD is a systemic disease with complications such as obesity, which is closely related to glucose and lipid metabolism. Obesity is associated with comorbidities such as dyslipidaemia, hypertension and diabetes.
The pathogenesis mechanism of MAFLD is complex and involves several factors such as mitochondrial dysfunction, oxidative stress, and increased free fatty acids (FFA). The 'multi-hit' theory explains how lifestyle, environmental and genetic factors contribute to the development of MAFLD. The gut microbiota also plays an important role in the development of MAFLD through the gut-liver axis, where microbiota imbalance can lead to inflammation and liver damage.
Research shows the microbiota composition in MAFLD patients is different from healthy people, with an increase in Proteobacteria and Actinobacteria and a decrease in butyrate-producing bacteria. Interventions with probiotics and prebiotics (synbiotics) have been shown to reduce liver fibrosis and improve metabolic profiles. The investigators are interested in assessing the effects of synbiotics on changes in metabolic biomarkers, insulin, TNF-α, and gut microbiota in MAFLD patients.
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)
盲法说明
Drug coding and group assignment are done by the pharmacy, where the investigator only receives data in the form of sample coding but does not know whether the coded sample received an intervention or control.
入排标准
- 年龄范围
- 25 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients aged 25-55 years
- •Patients are willing to become research respondents after filling out informed consent
- •Patients can and are willing to consume supplements orally within a predetermined time
- •Patients are willing to record compliance with taking supplements in a diary that has been provided
- •Patients diagnosed with MAFLD by FibroScan interpreted by a specialist in gastroenterology-hepatology with a CAP score ≥263 dB/m
排除标准
- •Patients with hepatitis (hepatitis B, hepatitis C, and autoimmune hepatitis) and alcoholic liver disease, cirrhosis of the liver
- •Patients who are pregnant, or breastfeeding or in a programme to become pregnant during participation in this study.
- •Patients with a history of alcohol consumption >40 g/day.
- •Patients with a history of decompensated disease including ascites, encephalopathy, variceal haemorrhage
- •Patients with Hepatocellular Carcinoma (HCC)
- •Patients with a history of bowel resection or bariatric surgery Patients with chronic inflammatory bowel disease (IBD)
- •Patients with a history of antibiotic use or probiotic/prebiotic/synbiotic consumption in the past 1 month
- •Use of Vitamin E and omega-3 fatty acids
- •Patients who were not hospitalised in the last month and therefore did not have any food restrictions related to their illness.
结局指标
主要结局
Complete Hematology
时间窗: 3 months
Complete Hematology analysis before and after intervention
Insulin
时间窗: 3 months
Insulin test results were taken before and after the intervention
TNF-alpha
时间窗: 3 months
TNF-alpha test results were taken before and after the intervention
CRP (C-Reactive Protein)
时间窗: 3 months
Analyzing C-Reactive Protein (CRP) before and after intervention
Metabolic Profile
时间窗: 3 months
Analyzing fasting glucose and HbA1C before and after the intervention
次要结局
- Alpha Diversity of Gut Microbioata(4 months)
- Anti-HCV(3 months)
- HBsAg (Hepatitis B Surface Antigen)(3 months)
- Beta Diversity of Gut Microbioata(4 months)
研究者
Adriyan Pramono
Lecturer
Universitas Diponegoro