SarcopeniaNCT03080129
Microbiome and Sarcopenia in Patients With Liver Cirrhosis
A study testing Fresubin energy in people with Sarcopenia and Liver Cirrhosis, run by Medical University of Graz at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia, Liver Cirrhosis
- What is being tested?
- Fresubin energy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteAustria
- Study dates
- 11 Apr 2017to Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
Medical University Graz
Graz
Vanessa Stadlbauer-Köllner, MD, 0043 316 385 ext. 82282, vanessa.stadlbauer@medunigraz.at
About this study
Official title: Microbiome and Sarcopenia in Patients With Liver Cirrhosis: A Prospective Controlled Cohort Study
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.
Read the 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.
- Conditions
- Sarcopenia, Liver Cirrhosis
- Being tested
- Fresubin energy
- Keywords
- Liver cirrhosis, Sarcopenia, Microbiome
- Medical subject headings
- Sarcopenia, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fresubin energyDietary supplement
dietary protein energy supplement
| Study group | Role | What they receive |
|---|---|---|
| Cirrhosis + sarcopenia | Experimental | Patients with cirrhosis will receive 200ml of an oral nutritional supplement daily for 7 days. Receives: Dietary Supplement: Fresubin energy |
| Control | No intervention | Patients with sarcopenia and no evidence of cirrhosis and healthy controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alpha diversity
16s rDNA sequencing of the stool microbiome
Measured: day 1
Secondary outcomes (22)
Zonulin
ELISA
Measured: day 1
diamino-oxidase
ELISA
Measured: day 1, day 7
Calprotectin
ELISA
Measured: day 1
Gut permeability
marker panel
Measured: change between day 1 and day 7
taxonomic composition of the microbiome
16s rDNA sequencing of the stool microbiome
Measured: day 1
taxonomic composition of the microbiome
16s rDNA sequencing of the stool microbiome
Measured: change between day 1 and day 7
lipopolysaccharide
HEK blue cell assay
Measured: day 1
sCD14
ELISA
Measured: day 1
lipopolysaccharide binding protein
ELISA
Measured: day 1
bacterial DNA
HEK blue cell assay
Measured: day 1
bacterial translocation
marker panel
Measured: change between day 1 and day 7
cytokine panel
Bead array
Measured: day 1
carboxylated proteins
ELISA
Measured: day 1
advanced oxidation end products
ELISA
Measured: day 1
inflammation
marker panel
Measured: change between day 1 and day 7
myostatin
ELISA
Measured: day 1
fibroblast growth factor 21
ELISA
Measured: day 1
insulin like growth factor 1
ELISA
Measured: day 1
Irisin
ELISA
Measured: day 1
nutritional status
Questionnaire
Measured: day 1
Sarcopenia
MR/CT scan
Measured: day 1
face portrait
face portraits "selfies" will be obtained and AI algorithms will be used to diagnose sarcopenia from selfies
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2017
- Study start11 Apr 2017
- Primary completionDec 2028 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03080129
- Sponsor's protocol ID
- SAR
- Status last verified
- Oct 2026
- First submitted
- 1 Mar 2017
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Haller R, Feldbacher N, Furst S, Woltsche J, Gulden L, Schwarzl J, Traub J, Madl T, Habisch H, Horvath A, Stadlbauer V. Clinical and Mechanistic Association Between Intestinal Permeability and the Gut Microbiome in Cirrhosis: Role of Phascolarctobacterium. United European Gastroenterol J. 2026 Jul;14(6):e70262. doi: 10.1002/ueg2.70262.
PubMed 42438428Woltsche J, Pacher-Deutsch C, Furst S, Gulden L, Schwarzl J, Feldbacher N, Nepel M, Celcer L, Hasl N, Rieper V, Stadlbauer V, Horvath A. Microbial Dysbiosis in the Urinary Microbiome of Patients With Cirrhosis. Am J Gastroenterol. 2026 Jan 1;121(1):262-267. doi: 10.14309/ajg.0000000000003634. Epub 2025 Jul 7.
PubMed 40622440
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbiome and Sarcopenia in Patients With Liver Cirrhosis: A Prospective Controlled Cohort Study
- ClinicalTrials.gov ID
- NCT03080129
- Acronym / sponsor ID
- SAR
- Conditions
- Sarcopenia, Liver Cirrhosis
- Keywords
- Liver cirrhosis, Sarcopenia, Microbiome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 11 Apr 2017 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 15 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cirrhosis + sarcopenia | Experimental | Dietary Supplement: Fresubin energyPatients with cirrhosis will receive 200ml of an oral nutritional supplement daily for 7 days. |
| Control | No intervention | –Patients with sarcopenia and no evidence of cirrhosis and healthy controls |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fresubin energydietary protein energy supplement | Dietary supplement | Cirrhosis + sarcopenia |
Primary outcome
Alpha diversity
Time frame: day 1
16s rDNA sequencing of the stool microbiome
22 secondary outcomes
Zonulin
Time frame: day 1
diamino-oxidase
Time frame: day 1, day 7
Calprotectin
Time frame: day 1
Gut permeability
Time frame: change between day 1 and day 7
taxonomic composition of the microbiome
Time frame: day 1
taxonomic composition of the microbiome
Time frame: change between day 1 and day 7
lipopolysaccharide
Time frame: day 1
sCD14
Time frame: day 1
lipopolysaccharide binding protein
Time frame: day 1
bacterial DNA
Time frame: day 1
bacterial translocation
Time frame: change between day 1 and day 7
cytokine panel
Time frame: day 1
carboxylated proteins
Time frame: day 1
advanced oxidation end products
Time frame: day 1
inflammation
Time frame: change between day 1 and day 7
myostatin
Time frame: day 1
fibroblast growth factor 21
Time frame: day 1
insulin like growth factor 1
Time frame: day 1
Irisin
Time frame: day 1
nutritional status
Time frame: day 1
Sarcopenia
Time frame: day 1
face portrait
Time frame: day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Derived from this study: PubMed 42438428Haller R, Feldbacher N, Furst S, Woltsche J, Gulden L, Schwarzl J, Traub J, Madl T, Habisch H, Horvath A, Stadlbauer V. Clinical and Mechanistic Association Between Intestinal Permeability and the Gut Microbiome in Cirrhosis: Role of Phascolarctobacterium. United European Gastroenterol J. 2026 Jul;14(6):e70262. doi: 10.1002/ueg2.70262.
- Derived from this study: PubMed 40622440Woltsche J, Pacher-Deutsch C, Furst S, Gulden L, Schwarzl J, Feldbacher N, Nepel M, Celcer L, Hasl N, Rieper V, Stadlbauer V, Horvath A. Microbial Dysbiosis in the Urinary Microbiome of Patients With Cirrhosis. Am J Gastroenterol. 2026 Jan 1;121(1):262-267. doi: 10.14309/ajg.0000000000003634. Epub 2025 Jul 7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fresubin energy in people with Sarcopenia and Liver Cirrhosis, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vanessa Stadlbauer-Köllner, AssocProf Dr (+4331638582282, vanessa.stadlbauer@medunigraz.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alpha diversity (time frame: day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03080129, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.