EUCTR2022-002924-11-AT进行中（未招募）1 期
An observational study on the effect of L-ornithine-L-aspertate (LOLA) on the Flavonifractor abundance in the gut microbiome in liver cirrhosis - LOLAbiome
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- CBmed GmbH
- 入组人数
- 55
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
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
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 44
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 11
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 (•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
研究者
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