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NCT05737030
Effect of L-ornithine-L-aspertate (LOLA) on the Gut Microbiome
Conditions: Cirrhosis
Sex: All
Ages: 18 Years – N/A
Phase: PHASE4
Enrollment: 55
Sponsor: Medical University of Graz
Location: Austria
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)
Eligibility Criteria
Inclusion Criteria:• Liver cirrhosis (clinical/radiological/histological diagnosis)Indication for LOLA use (covert or over hepatic encephalopathy, Grad 0-2))Written informed consentAge 18 -100 yearsExclusion 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 encephalopathyRifaximin or any other antibiotic therapy within the past 4 weeksIntake of LOLA in the past four weeks before inclusionIntake of L-dopamineRenal insufficiency with a serum creatinine >3mg/dlHepatocellular carcinoma BCLC D under best supportive careInability to give informed consentPregnancy or breastfeedingParticipation in another interventional trial within the last 30 days
Source: ClinicalTrials.gov (NCT05737030). StuddyBuddy aggregates publicly available trial information.