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

NCT ID: NCT05737030

Last Updated: 2025-02-10

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-06
• Study Completion Date: 2025-12-31

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)

Detailed Description

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.

Conditions

Cirrhosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

L-ornithine-L-aspertate

L-ornithine-L-aspertate 18g per day

Group Type: EXPERIMENTAL

L-ornithine L-aspartate

Intervention Type: DRUG

Amino acid combination

Interventions

L-ornithine L-aspartate

Amino acid combination

Intervention Type: DRUG

Other Intervention Names

Hepa-Merz

Eligibility 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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CBmed Ges.m.b.H.

OTHER

Sponsor Role: collaborator

Medical University of Graz

OTHER

Sponsor Role: lead

Responsible Party

Vanessa Stadlbauer-Koellner, MD

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Internal Medicine, Medical University of Graz

Graz, , Austria

Countries

Austria

Other Identifiers

2022-002924-11

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

LOLAbiome

Identifier Type: -

Identifier Source: org_study_id