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

Medical University of Graz

Status and phase: Active, not recruiting; Phase 4

Conditions: Cirrhosis

Treatments: Drug: L-ornithine L-aspartate

Study type: Interventional

Funder types: Other

Identifiers

NCT05737030

LOLAbiome

2022-002924-11 (EudraCT Number)

Details and patient eligibility

About

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)

Full 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.

Enrollment: 55 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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55 participants in 1 patient group

L-ornithine-L-aspertate

Experimental group

Description:

L-ornithine-L-aspertate 18g per day

Treatment:

Drug: L-ornithine L-aspartate