NCT03080129

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
7mo left

Started Apr 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Apr 2017Dec 2026

First Submitted

Initial submission to the registry

March 1, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 15, 2017

Completed
27 days until next milestone

Study Start

First participant enrolled

April 11, 2017

Completed
9.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

October 9, 2024

Status Verified

October 1, 2024

Enrollment Period

9.6 years

First QC Date

March 1, 2017

Last Update Submit

October 7, 2024

Conditions

SarcopeniaLiver Cirrhosis

Keywords

Liver cirrhosisSarcopeniaMicrobiome

Outcome Measures

Primary Outcomes (1)

  • Alpha diversity

    16s rDNA sequencing of the stool microbiome

    day 1

Secondary Outcomes (22)

  • Zonulin

    day 1

  • diamino-oxidase

    day 1, day 7

  • Calprotectin

    day 1

  • Gut permeability

    change between day 1 and day 7

  • taxonomic composition of the microbiome

    day 1

  • +17 more secondary outcomes

Study Arms (2)

Cirrhosis + sarcopenia

EXPERIMENTAL

Patients with cirrhosis will receive 200ml of an oral nutritional supplement daily for 7 days.

Dietary Supplement: Fresubin energy

Control

NO INTERVENTION

Patients with sarcopenia and no evidence of cirrhosis and healthy controls

Interventions

Fresubin energyDIETARY_SUPPLEMENT

dietary protein energy supplement

Cirrhosis + sarcopenia

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University Graz

Graz, Austria

RECRUITING

Related Publications (1)

  • Woltsche 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.

    PMID: 40622440DERIVED

MeSH Terms

Conditions

SarcopeniaLiver Cirrhosis

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsLiver DiseasesDigestive System DiseasesFibrosisPathologic Processes

Central Study Contacts

Vanessa Stadlbauer-Köllner, AssocProf Dr

CONTACT

+4331638582282vanessa.stadlbauer@medunigraz.at

Julia Haberl, BSc

CONTACT

+4331638580777julia.haberl@klinikum-graz.at

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2017

First Posted

March 15, 2017

Study Start

April 11, 2017

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

October 9, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)