Investigating the gut microbiome's role in muscle loss in liver cirrhosis patients
Microbiome and Sarcopenia in Patients With Liver Cirrhosis: A Prospective Controlled Cohort Study
This study is testing how changes in gut bacteria affect muscle loss in people with liver cirrhosis and whether improving nutrition can help.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Medical University of Graz Academic / other |
| Locations | 1 site (Graz) |
| Trial ID | NCT03080129 on ClinicalTrials.gov |
What this trial studies
This study explores the relationship between changes in the gut microbiome and sarcopenia in patients with liver cirrhosis. It aims to understand how alterations in the microbiome contribute to protein-energy malnutrition and muscle loss, which are common complications in these patients. The study will involve hospitalized patients diagnosed with cirrhosis and will assess the impact of nutritional interventions on the microbiome. By utilizing imaging techniques like CT or MRI, the severity of sarcopenia will be objectively measured.
Who should consider this trial
Good fit: Ideal candidates include hospitalized adults over 18 years old with a clinical diagnosis of liver cirrhosis.
Not a fit: Patients with advanced hepatic encephalopathy or severe cognitive disorders, as well as those with advanced liver cancer, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved nutritional strategies that mitigate muscle loss and enhance the quality of life for patients with liver cirrhosis.
How similar studies have performed: While the relationship between the microbiome and sarcopenia is being explored, this specific approach is relatively novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Graz
- Medical University Graz — Graz, Austria (Recruiting)
Study contacts
- Study coordinator: Vanessa Stadlbauer-Köllner, AssocProf Dr
- Email: vanessa.stadlbauer@medunigraz.at
- Phone: +4331638582282
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.