Characterization of Gut Microbiota in Chronic Liver Disease With Decreased Muscle Mass

The purpose of this study was to confirm the presence of specific gut microbiota observed in patients with sarcopenia among patients who agreed to analyze gut microbiota through stool among multi-center chronic liver disease cohort patients.

Study Overview

• Status: Completed
• Conditions: Sarcopenia; Gastrointestinal Microbiome; Liver Disease Chronic
• Intervention / Treatment: Diagnostic test: Sarcopenia_CT

Detailed Description

The effect of gut microbiota on liver disease is also well known and many studies are ongoing. A recently published study summarized the differences in the composition of gut microbiota in non-alcoholic fatty liver, steatohepatitis, and cirrhosis, and reported that metabolites from the changed gut microbiota may be a factor influencing non-alcoholic fatty liver disease (NAFLD) progression. These changes in gut microbiota composition have been reported to affect clinical outcomes in patients by causing an increase in endotoxin, a change in bile acid metabolism, and a decrease in short chain fatty acid. In particular, the reduction of short chain fatty acid is known to be associated with the occurrence of sarcopenia. Sarcopenia, which is common in patients with cirrhosis, which is a representative chronic liver disease, is well known as a poor prognostic factor for patients. Therefore, this study aims to analyze the distribution of gut microbiota observed in patients with sarcopenia through the gut microbiota investigated in the chronic liver disease cohort patient group and the characteristics of the distribution of gut microbiota for each disease corresponding to chronic liver disease.

• Study Type: Observational
• Enrollment (Actual): 283

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gangwon-do
    • Chuncheon, Gangwon-do, Korea, Republic of, 24253
      • Department of Internal Medicine, Hallym University Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 24 years to 82 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

From January 2017 to December 2019, 489 patients who agreed to collect feces among the cohort patients with chronic liver disease in five hospitals under the Hallym University Medical Center were surveyed.

Description

Inclusion Criteria:

• 1. Patients who have chronic liver disease (chronic liver disease cohort): alcohol liver disease, non-alcoholic liver disease, liver cirrhosis 2. Patients who consented to a study confirming the gut microbiota 3. Patients with abdominal computed tomography scan taken one month before or after submitting stool for gut microbiota analysis

Exclusion Criteria:

• Patients whose height and weight records are missing from the chart review

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Chronic liver disease; non-alcohol liver disease, alcohol liver disease, liver cirrhosis	Diagnostic test: Sarcopenia_CT; measurement of skeletal muscle through abdominal computed tomography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fecal gut microbiota between sarcopenia group and non-sarcopenia group	Compare the species and proportions of the gut microbiota between sarcopenia group and non-sarcopenia group	2 years

Collaborators and Investigators

• Sponsor: Chuncheon Sacred Heart Hospital
• Collaborators: Hangang Sacred Heart Hospital; Yonsei University; Hallym University Medical Center; Dongtan Sacred Heart Hospital; Kangdong Sacred Heart Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2017
• Primary Completion (Actual): April 30, 2019
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: February 6, 2023
• First Submitted That Met QC Criteria: February 6, 2023
• First Posted (Actual): February 15, 2023

Study Record Updates

• Last Update Posted (Actual): February 15, 2023
• Last Update Submitted That Met QC Criteria: February 6, 2023
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Liver Diseases; Sarcopenia
• Other Study ID Numbers: microbiota_CLD-sarcopenia

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No