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Clinical Trials in Austria / NCT03080129
Recruiting Not applicable

Microbiome and Sarcopenia in Patients With Liver Cirrhosis

NCT03080129 · tracked via the Priya Life Science Austria tracker
Phase
Not applicable
Started
2017-04-11
Last updated
2024-10-09

Condition(s) studied

SarcopeniaLiver Cirrhosis

Investigational drug(s) / intervention(s)

Fresubin energy

Fresubin energy: dietary protein energy supplement

Study summary

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

Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
Accepted
Inclusion Criteria: * 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 Exclusion Criteria: * 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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Medical University Graz Graz Austria Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03080129 on ClinicalTrials.gov ↗ ← All trials in Austria