Microbiome and Sarcopenia in Patients With Liver Cirrhosis

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorMedical University of Graz

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Fresubin energy

    Dietary supplement

    dietary protein energy supplement

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Cirrhosis + sarcopeniaExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Alpha diversity

16s rDNA sequencing of the stool microbiome

Time frame
day 1

Secondary outcomes

1

Zonulin

ELISA

Time frame
day 1
2

diamino-oxidase

ELISA

Time frame
day 1, day 7
3

Calprotectin

ELISA

Time frame
day 1
4

Gut permeability

marker panel

Time frame
change between day 1 and day 7

Other outcomes

Sponsors and contacts

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