An Observational Study on the Effect of L-ornithine-L-aspertate (LOLA) on the Flavonifractor Abundance in the Gut Microbiome in Liver Cirrhosis

LOLAbiome

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)

2023-02-06

2024-10-01

2025-12-01

Recruiting

Early phase I

55

Inclusion Criteria: * • 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 Exclusion Criteria: * • 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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 55, 'type': 'ESTIMATED'}}

2024-03-12