CompletedPhase 4
Effect of L-ornithine-L-aspertate (LOLA) on the Gut Microbiome
Key facts
- Who runs it
- Medical University of Graz
- Where
- Austria1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- Phase
- Phase 4
- People taking part
- 52 people enrolled
- Started
- 6 Feb 2023
- Ended
- 31 Dec 2025
- Type of study
- Interventional
- Treatments tested
- L-ornithine L-aspartate
- Record updated
- 9 October 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 2 criteriaShow less
Who can take part
- • 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
Who cannot take part
- • 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
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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)
The group in the trial
- L-ornithine-L-aspertateTreatment being tested
L-ornithine-L-aspertate 18g per day
Treatment: L-ornithine L-aspartate
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- An Observational Study on the Effect of L-ornithine-L-aspertate (LOLA) on the Flavonifractor Abundance in the Gut Microbiome in Liver Cirrhosis
- Publications
- An observational study on the effect of l-ornithine-l-aspartate (LOLA) on the gut microbiome in liver cirrhosis. A single center phase 4 study.Clinical nutrition (Edinburgh, Scotland), 2026
- Record updated
- 9 October 2026