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)

An observational study on the effect of L-ornithine-L-aspertate (LOLA) on the Flavonifractor abundance in the gut microbiome in liver cirrhosis - LOLAbiome

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2022-002924-11-AT

Enrollment

Registered

2023-01-26

Start date

2023-01-09

Completion date

Unknown

Last updated

2024-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver cirrhosis with covert or overt hepatic encephalopathy (grade 0-2) MedDRA version: 20.0 Level: LLT Classification code 10024667 Term: Liver cirrhosis System Organ Class: 100000004871 MedDRA version: 20.0 Level: LLT Classification code 10014630 Term: Encephalopathy hepatic System Organ Class: 100000004852

Interventions

Trade Name: Hepa-Merz-3 g Granulat Product Name: Hepa-Merz 3 g Granulat Pharmaceutical Form: Granules

Eligibility

Sex/Gender

All

Inclusion 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 44 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 11

Exclusion criteria

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 (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

Design outcomes

Primary

Measure	Time frame
Main Objective: To test whether L-ornithine-L-aspartate (LOLA) alters gut microbiome composition (Flavonifractor) in liver cirrhosis with covert or overt hepatic encephalopathy (Grade 0-2);Secondary Objective: To test whether LOLA alters gut microbiome function in liver cirrhosis To test whether LOLA alters metabolite composition in stool, serum or urine in liver cirrhosis To test whether LOLA improves gut permeability and inflammation in liver cirrhosis To test whether LOLA improves elevated ammonia levels in blood To test whether LOLA improves muscle function in cirrhosis To test whether LOLA prevents complications of cirrhosis ;Primary end point(s): Increase of the genus Flavonifractor in the gut microbiome after 3 months of LOLA treatment;Timepoint(s) of evaluation of this end point: 3 months	—

Measure

Time frame

Main Objective: To test whether L-ornithine-L-aspartate (LOLA) alters gut microbiome composition (Flavonifractor) in liver cirrhosis with covert or overt hepatic encephalopathy (Grade 0-2);Secondary Objective: To test whether LOLA alters gut microbiome function in liver cirrhosis To test whether LOLA alters metabolite composition in stool, serum or urine in liver cirrhosis To test whether LOLA improves gut permeability and inflammation in liver cirrhosis To test whether LOLA improves elevated ammonia levels in blood To test whether LOLA improves muscle function in cirrhosis To test whether LOLA prevents complications of cirrhosis ;Primary end point(s): Increase of the genus Flavonifractor in the gut microbiome after 3 months of LOLA treatment;Timepoint(s) of evaluation of this end point: 3 months

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Secondary

Measure	Time frame
Secondary end point(s): Change in alpha diversity of the gut microbiome after 3 months of LOLA treatment Change in beta diversity of the gut microbiome after 3 months of LOLA treatment Change in taxonomic composition (beyond Flavonifractor) of the gut microbiome after 3 months of LOLA treatment Change in predicted gut microbiome function after 3 months of LOLA treatment Change in stool, serum or urine metabolite composition after 3 months of LOLA treatment Change in biomarkers of gut permeability after 3 months of LOLA treatment Change in handgrip strength after 3 months of LOLA treatment Change in gait speed and balance after 3 months of LOLA treatment Change in ammonia blood levels after 3 months of LOLA treatment Change in anthropometric parameters (Mid-arm circumference and triceps fold thickness) after 3 months of LOLA treatment Change in quality of life after 3 months of LOLA treatment Occurrence of complications of cirrhosis during the study period Occurrence of side effects during the study period ;Timepoint(s) of evaluation of this end point: 3 months	—

Measure

Time frame

Secondary end point(s): Change in alpha diversity of the gut microbiome after 3 months of LOLA treatment Change in beta diversity of the gut microbiome after 3 months of LOLA treatment Change in taxonomic composition (beyond Flavonifractor) of the gut microbiome after 3 months of LOLA treatment Change in predicted gut microbiome function after 3 months of LOLA treatment Change in stool, serum or urine metabolite composition after 3 months of LOLA treatment Change in biomarkers of gut permeability after 3 months of LOLA treatment Change in handgrip strength after 3 months of LOLA treatment Change in gait speed and balance after 3 months of LOLA treatment Change in ammonia blood levels after 3 months of LOLA treatment Change in anthropometric parameters (Mid-arm circumference and triceps fold thickness) after 3 months of LOLA treatment Change in quality of life after 3 months of LOLA treatment Occurrence of complications of cirrhosis during the study period Occurrence of side effects during the study period ;Timepoint(s) of evaluation of this end point: 3 months

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Countries

Austria

Contacts

Public ContactClinical Trial Information

CBmed

angela.horvath@medunigraz.at

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026