A Phase 4 interventional study of L-ornithine L-aspartate in Cirrhosis, sponsored by Medical University of Graz. Active, not recruiting at 1 site in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-10.
Sponsored by Medical University of Graz · Phase 4, Interventional, and Treatment
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)
Liver cirrhosis is associated with gut microbiome dysbiosis, which may drive intestinal inflammation, gut barrier dysfunction and the development of complications. LOLA is a well-established drug against elevated ammonia levels that contribute to hepatic encephalopathy and sarcopenia. In a recent retrospective study, LOLA has been shown to improve gut microbiome dysbiosis.
In this study we aim to investigate whether LOLA therapy over three months in patients with liver cirrhosis (irrespective of the etiology) and covert or overt hepatic encephalopathy (HE) leads to an improvement in gut microbiome dysbiosis, as well as markers of gut permeability, inflammation, muscle function and ammonia levels.
1,642 studies on the registry are indexed under Liver Cirrhosis; 358 are open to participants now.
This study's planned enrollment of 55 is below the median of 72 across 995 interventional studies indexed under Liver Cirrhosis.
Browse Liver Cirrhosis studies →Medical University of Graz is the lead sponsor of 459 studies on the registry; 98 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Liver cirrhosis (clinical/radiological/histological diagnosis)
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)
L-ornithine-L-aspertate 18g per day
Drug: L-ornithine L-aspartate
Amino acid combination
Also known as: Hepa-Merz
Microbiome
Increase of the genus Flavonifractor in the gut microbiome after 3 months of LOLA treatment
Time frame: 3 months
Alpha diversity
Change in alpha diversity of the gut microbiome after 3 months of LOLA treatment
Time frame: 3 months
Beta diversity
Change in beta diversity of the gut microbiome after 3 months of LOLA treatment
Time frame: 3 months
Taxonomic composition
Change in taxonomic composition (beyond Flavonifractor) of the gut microbiome after 3 months of LOLA treatment
Time frame: 3 months
Predicted metagenomics
Change in predicted gut microbiome function after 3 months of LOLA treatment
Time frame: 3 months
Metabolomics
Change in stool, serum or urine metabolite composition after 3 months of LOLA treatment
Time frame: 3 months
Gut permeability
Change in biomarkers of gut permeability (zonulin, DAO, sCD14, LBP) after 3 months of LOLA treatment
Time frame: 3 months
Handgrip strength
Change in handgrip strength after 3 months of LOLA treatment
Time frame: 3 months
Muscle function
Change in gait speed and balance after 3 months of LOLA treatment
Time frame: 3 months
Ammonia in serum
Change in ammonia blood levels after 3 months of LOLA treatment
Time frame: 3 months
Mid-arm circumference and triceps fold thickness
Change in anthropometric parameters (Mid-arm circumference and triceps fold thickness) after 3 months of LOLA treatment
Time frame: 3 months
short form (SF)-36
Change in quality of life after 3 months of LOLA treatment, 8 domains, 0-100 points, higher points indicate higher quality of life
Time frame: 3 months
Plan to share: Yes — Sequencing data will be deposited in an open access repository together with metadata
Supporting information: Study protocol, Sap, Icf, Csr
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Medical University of Graz