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

NCT05737030 | Active Not Recruiting Phase 4

• 2 other identifiers: LOLAbiome2022-002924-11
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Cirrhosis

Outcome Measures

Primary Outcomes (1)

• Microbiome

  Increase of the genus Flavonifractor in the gut microbiome after 3 months of LOLA treatment

  3 months

Secondary Outcomes (11)

• Alpha diversity

  3 months

• Beta diversity

  3 months

• Taxonomic composition

  3 months

• Predicted metagenomics

  3 months

• Metabolomics

  3 months

Study Arms (1)

L-ornithine-L-aspertate

EXPERIMENTAL

L-ornithine-L-aspertate 18g per day

Drug: L-ornithine L-aspartate

Interventions

L-ornithine L-aspartate DRUG

Amino acid combination

Also known as: Hepa-Merz

L-ornithine-L-aspertate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Medical University of Graz: lead
• CBmed Ges.m.b.H.: collaborator

Study Sites (1)

Department of Internal Medicine, Medical University of Graz

Graz, 8010, Austria

Location

Related Publications (1)

• Habich D, Horvath A, Feldbacher N, Rebol L, Nepel M, Madl T, Habisch HJ, Baumann-Durchschein F, Furst S, Plank J, Rainer F, Spindelbock W, Stauber RE, Tatscher E, Wagner M, Zollner G, Stadlbauer V. 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. Clin Nutr. 2025 Nov 29;56:106522. doi: 10.1016/j.clnu.2025.11.007. Online ahead of print.

  PMID: 41406626 DERIVED

MeSH Terms

Conditions

Fibrosis

Interventions

ornithylaspartate; Silybin

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Silymarin; Flavonolignans; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 12, 2023
• First Posted: February 21, 2023
• Study Start: February 6, 2023
• Primary Completion: July 23, 2024
• Study Completion: December 1, 2025
• Last Updated: February 10, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 2023
• Access Criteria: open access

Locations

AU (1)