An Observational Study on the Effect of L-ornithine-L-aspertate (LOLA) on the Flavonifractor Abundance in the Gut Microbiome in Liver Cirrhosis
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Microbiome
研究概览
简要总结
Study to test the effect of the drug "L-ornithine.L-aspertate" (LOLA) on microorganisms in the digestive tract in patients with liver cirrhosis (damage of the liver due to liver disease)
详细描述
Liver cirrhosis is associated with gut microbiome dysbiosis, which may drive intestinal inflammation, gut barrier dysfunction and the development of complications. LOLA is a well-established drug against elevated ammonia levels that contribute to hepatic encephalopathy and sarcopenia. In a recent retrospective study, LOLA has been shown to improve gut microbiome dysbiosis.
In this study we aim to investigate whether LOLA therapy over three months in patients with liver cirrhosis (irrespective of the etiology) and covert or overt hepatic encephalopathy (HE) leads to an improvement in gut microbiome dysbiosis, as well as markers of gut permeability, inflammation, muscle function and ammonia levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Liver cirrhosis (clinical/radiological/histological diagnosis)
- •Indication for LOLA use (covert or over hepatic encephalopathy, Grad 0-2))
- •Written informed consent
- •Age 18 -100 years
排除标准
- •• Allergy to LOLA or its constituents, or to medications with a similar chemical structure (oral nutritional supplements are allowed when stable >/= 8 weeks before and during the study)
- •Recent (</= 8 weeks) changes of the dose of the lactulose therapy for hepatic encephalopathy
- •Rifaximin or any other antibiotic therapy within the past 4 weeks
- •Intake of LOLA in the past four weeks before inclusion
- •Intake of L-dopamine
- •Renal insufficiency with a serum creatinine >3mg/dl
- •Hepatocellular carcinoma BCLC D under best supportive care
- •Inability to give informed consent
- •Pregnancy or breastfeeding
- •Participation in another interventional trial within the last 30 days
研究组 & 干预措施
L-ornithine-L-aspertate
L-ornithine-L-aspertate 18g per day
干预措施: L-ornithine L-aspartate (Drug)
结局指标
主要结局
Microbiome
时间窗: 3 months
Increase of the genus Flavonifractor in the gut microbiome after 3 months of LOLA treatment
次要结局
- Alpha diversity(3 months)
- Beta diversity(3 months)
- Taxonomic composition(3 months)
- Predicted metagenomics(3 months)
- Metabolomics(3 months)
- Gut permeability(3 months)
- Handgrip strength(3 months)
- Muscle function(3 months)
- Ammonia in serum(3 months)
- Mid-arm circumference and triceps fold thickness(3 months)
- short form (SF)-36(3 months)
研究者
Vanessa Stadlbauer-Koellner, MD
Principal investigator
Medical University of Graz