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

Phase 4Active Not RecruitingNCT05737030

Medical University of Graz55 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cirrhosis

Interventions

L-ornithine L-aspartateDRUG

Amino acid combination

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 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 (\</= 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

Locations (1)

Department of Internal Medicine, Medical University of Graz

Graz, Austria

Outcomes

Primary Outcomes

Microbiome

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

Time frame: 3 months

Secondary Outcomes

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

Data from ClinicalTrials.gov

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