Microbiome and Sarcopenia in Patients With Liver Cirrhosis: A Prospective Controlled Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Alpha diversity
研究概览
简要总结
Protein-energy malnutrition (PEM) occurs in 65-90% of patients with liver cirrhosis. Severity of malnutrition correlates with progression of liver disease and leads to sarcopenia in 30-70% of cirrhotic patients. Malnutrition and sarcopenia are associated with an increased risk of complications and mortality.
In cirrhosis the gut microbiome is altered leading to increased gut permeability, bacterial translocation and inflammation. Since the microbiome is involved in nutrient uptake and metabolism, it is hypothesized that microbiome alterations contribute to sarcopenia. A prospective controlled cohort study to investigate the interrelation of microbiome changes and sarcopenia in cirrhosis will be conducted. Furthermore the effect of nutritional interventions on the microbiome in cirrhosis will be studied. From this study information on how the gut microbiome composition and sarcopenia are associated in cirrhosis and if modulation of the gut microbiome by nutritional interventions is feasible will be collected.
详细描述
Scientific background
Protein-energy malnutrition (PEM) occurs in 65-90% of patients with chronic liver disease. PEM is caused by various factors including poor dietary intake, loss of appetite, decreased hepatic protein synthesis, malabsorption and hypermetabolism. It is associated with an increased risk of complications including ascites, hepatic encephalopathy, variceal bleeding, hepatorenal syndrome and mortality. There is a direct relation between the progression of the liver disease and the severity of malnutrition.
Malnutrition and sarcopenia in liver cirrhosis patients
PEM leads to sarcopenia as a common, but frequently overlooked, complication. Sarcopenia is defined as a decrease in muscle mass two standard deviations below the healthy young adult mean. Sarcopenia is associated with aging, chronic diseases and malignancy. To determine the severity of muscle wasting, computed tomography scan (CT) or magnetic resonance imaging (MRI) are an objective and reproducible technique. Sarcopenia negatively impacts on survival, correlates with the risk of infections, increases surgical risk and leads to a poor quality of life. Besides PEM also inflammation is of importance in the development of sarcopenia.
Diversity in the microbiome in patients with liver cirrhosis and association with sarcopenia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Hospitalized patients for any reason with clinical/radiological/histological diagnosis of cirrhosis
- •Age >18y
- •Informed consent
- •CT/MRI scan within +/-14 days of the baseline study visit
排除标准
- •Hepatic encephalopathy > grade 2 and or other cognitive disorder not allowing informed consent
- •advanced hepatocellular carcinoma
- •Any other condition or circumstance, which, in the opinion of the investigator, would affect the patient's ability to participate in the protocol
结局指标
主要结局
Alpha diversity
时间窗: day 1
16s rDNA sequencing of the stool microbiome
次要结局
- bacterial translocation(change between day 1 and day 7)
- Zonulin(day 1)
- diamino-oxidase(day 1, day 7)
- Calprotectin(day 1)
- sCD14(day 1)
- Gut permeability(change between day 1 and day 7)
- cytokine panel(day 1)
- carboxylated proteins(day 1)
- taxonomic composition of the microbiome(change between day 1 and day 7)
- fibroblast growth factor 21(day 1)
- bacterial DNA(day 1)
- myostatin(day 1)
- insulin like growth factor 1(day 1)
- lipopolysaccharide(day 1)
- lipopolysaccharide binding protein(day 1)
- advanced oxidation end products(day 1)
- Irisin(day 1)
- nutritional status(day 1)
- Sarcopenia(day 1)
- face portrait(day 1)
- inflammation(change between day 1 and day 7)