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)

Phase 1

• Conditions: iver cirrhosis with covert or overt hepatic encephalopathy (grade 0-2); MedDRA version: 20.0Level: LLTClassification code 10014630Term: Encephalopathy hepaticSystem Organ Class: 100000004852; MedDRA version: 20.0Level: LLTClassification code 10024667Term: Liver cirrhosisSystem Organ Class: 100000004871; Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

• Registration Number: EUCTR2022-002924-11-AT
• Lead Sponsor: CBmed GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-01-26
• Last Update Posted: 30 January 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 55

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

•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 (•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>To test whether LOLA alters metabolite composition in stool, serum or urine in liver cirrhosis<br>To test whether LOLA improves gut permeability and inflammation in liver cirrhosis<br>To test whether LOLA improves elevated ammonia levels in blood<br>To test whether LOLA improves muscle function in cirrhosis<br>To test whether LOLA prevents complications of cirrhosis <br>;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