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Microbiome and Sarcopenia in Patients With Liver Cirrhosis

Microbiome and Sarcopenia in Patients With Liver Cirrhosis: A Prospective Controlled Cohort Study

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03080129
Enrollment
120
Registered
2017-03-15
Start date
2017-04-11
Completion date
2026-12-31
Last updated
2024-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Cirrhosis, Sarcopenia

Keywords

Liver cirrhosis, Sarcopenia, Microbiome

Brief 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.

Detailed description

Scientific background Protein-energy malnutrition (PEM) occurs in 65-90% of patients with chronic liver disease. PEM is caused by various factors including poor dietary intake, loss of appetite, decreased hepatic protein synthesis, malabsorption and hypermetabolism. It is associated with an increased risk of complications including ascites, hepatic encephalopathy, variceal bleeding, hepatorenal syndrome and mortality. There is a direct relation between the progression of the liver disease and the severity of malnutrition. Malnutrition and sarcopenia in liver cirrhosis patients PEM leads to sarcopenia as a common, but frequently overlooked, complication. Sarcopenia is defined as a decrease in muscle mass two standard deviations below the healthy young adult mean. Sarcopenia is associated with aging, chronic diseases and malignancy. To determine the severity of muscle wasting, computed tomography scan (CT) or magnetic resonance imaging (MRI) are an objective and reproducible technique. Sarcopenia negatively impacts on survival, correlates with the risk of infections, increases surgical risk and leads to a poor quality of life. Besides PEM also inflammation is of importance in the development of sarcopenia. Diversity in the microbiome in patients with liver cirrhosis and association with sarcopenia. The gut microbiome of liver cirrhosis patients is altered compared to healthy individuals. Dysbiosis leads to an increased gut permeability, bacterial translocation and inflammation. This contributes to fibrogenesis and may also be related to hepatocarcinogenesis. Hence, new treatment approaches in cirrhosis focus on changing the microbial landscape. Modulation the gut microbiome may also be a strategy to reverse sarcopenia by reducing systematic inflammation. Hypothesis and aims There is an association between gut microbiome composition, gut permeability and the existence of sarcopenia in cirrhotic patients. Primary hypothesis: Diversity of the gut microbiome is reduced in liver cirrhosis patients with sarcopenia compared to those without sarcopenia or healthy controls. Secondary hypotheses: There is an association between gut microbiome composition, biomarker of gut permeability and bacterial translocation with the presence of sarcopenia in cirrhosis. Oral nutrition supplements (ONS) can influence the composition of the gut microbiome, gut permeability, bacterial translocation and inflammation. Sarcopenia can be diagnosed from patients portraits. Aims: to investigate: * the composition of the gut microbiome * biomarkers of gut permeability, bacterial translocation and inflammation * the incidence and severity of sarcopenia * the impact of oral nutrition supplements (ONS) on the gut microbiome * whether artificial intelligence can be used to diagnose sarcopenia from face portraits.

Interventions

DIETARY_SUPPLEMENTFresubin energy

dietary protein energy supplement

Sponsors

Medical University of Graz
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Alpha diversityday 116s rDNA sequencing of the stool microbiome

Secondary

MeasureTime frameDescription
diamino-oxidaseday 1, day 7ELISA
Calprotectinday 1ELISA
Gut permeabilitychange between day 1 and day 7marker panel
taxonomic composition of the microbiomeday 116s rDNA sequencing of the stool microbiome
lipopolysaccharideday 1HEK blue cell assay
sCD14day 1ELISA
lipopolysaccharide binding proteinday 1ELISA
bacterial DNAday 1HEK blue cell assay
bacterial translocationchange between day 1 and day 7marker panel
cytokine panelday 1Bead array
Zonulinday 1ELISA
advanced oxidation end productsday 1ELISA
inflammationchange between day 1 and day 7marker panel
myostatinday 1ELISA
fibroblast growth factor 21day 1ELISA
insulin like growth factor 1day 1ELISA
Irisinday 1ELISA
nutritional statusday 1Questionnaire
Sarcopeniaday 1MR/CT scan
face portraitday 1face portraits selfies will be obtained and AI algorithms will be used to diagnose sarcopenia from selfies
carboxylated proteinsday 1ELISA

Countries

Austria

Contacts

Primary ContactVanessa Stadlbauer-Köllner, AssocProf Dr
vanessa.stadlbauer@medunigraz.at+4331638582282
Backup ContactJulia Haberl, BSc
julia.haberl@klinikum-graz.at+4331638580777

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026