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

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Austria
Medical University Graz
RECRUITING
Graz
Contact Information
Primary
Vanessa Stadlbauer-Köllner, AssocProf Dr
vanessa.stadlbauer@medunigraz.at
+4331638582282
Backup
Julia Haberl, BSc
julia.haberl@klinikum-graz.at
+4331638580777
Time Frame
Start Date: 2017-04-11
Estimated Completion Date: 2026-12
Participants
Target number of participants: 120
Treatments
Experimental: Cirrhosis + sarcopenia
Patients with cirrhosis will receive 200ml of an oral nutritional supplement daily for 7 days.
No_intervention: Control
Patients with sarcopenia and no evidence of cirrhosis and healthy controls
Related Therapeutic Areas
Sponsors
Leads: Medical University of Graz

This content was sourced from clinicaltrials.gov