NCT03080129 Microbiome and Sarcopenia in Patients With Liver Cirrhosis
| NCT ID | NCT03080129 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medical University of Graz |
| Condition | Sarcopenia |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2017-04-11 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2017-04-11 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT03080129 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Sarcopenia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03080129 currently recruiting?
Yes, NCT03080129 is actively recruiting participants. Contact the research team at vanessa.stadlbauer@medunigraz.at for enrollment information.
Where is the NCT03080129 trial being conducted?
This trial is being conducted at Graz, Austria.
Who is sponsoring the NCT03080129 clinical trial?
NCT03080129 is sponsored by Medical University of Graz. The trial plans to enroll 120 participants.