About this trial
Protein-energy malnutrition (PEM) occurs in 65-90% of patients with liver cirrhosis. Severity of malnutrition correlates with progression of liver disease and leads to sarcopenia in 30-70% of cirrhotic patients. Malnutrition and sarcopenia are associated with an increased risk of complications and mortality.
In cirrhosis the gut microbiome is altered leading to increased gut permeability, bacterial translocation and inflammation. Since the microbiome is involved in nutrient uptake and metabolism, it is hypothesized that microbiome alterations contribute to sarcopenia. A prospective controlled cohort study to investigate the interrelation of microbiome changes and sarcopenia in cirrhosis will be conducted. Furthermore the effect of nutritional interventions on the microbiome in cirrhosis will be studied. From this study information on how the gut microbiome composition and sarcopenia are associated in cirrhosis and if modulation of the gut microbiome by nutritional interventions is feasible will be collected.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Hospitalized patients for any reason with clinical/radiological/histological diagnosis of cirrhosis
Age >18y
Informed consent
CT/MRI scan within +/-14 days of the baseline study visit
Disqualifiers
Hepatic encephalopathy > grade 2 and or other cognitive disorder not allowing informed consent
advanced hepatocellular carcinoma
Any other condition or circumstance, which, in the opinion of the investigator, would affect the patient's ability to participate in the protocol
Trial design
Parallel
Treatments tested in this trial
Fresubin energy
Dietary supplementdietary protein energy supplement
Treatment groups
Trial outcomes
Primary outcomes
Alpha diversity
16s rDNA sequencing of the stool microbiome
Secondary outcomes
Zonulin
ELISA
diamino-oxidase
ELISA
Calprotectin
ELISA
Gut permeability
marker panel
Sponsors and contacts
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