Effect of L-ornithine-L-aspertate (LOLA) on the Gut Microbiome

• Status: Recruiting
• Trial end date: 2025-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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)

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of Graz
• Collaborator: CBmed Ges.m.b.H.
• Treatments: N-Methylaspartate

Criteria

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 (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