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

Sarcopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05729269
• Other study ID #: microbiota_CLD-sarcopenia
• Status: Completed
• Start date: March 22, 2017
• Est. completion date: December 31, 2021

Study information

• Verified date: April 2021
• Source: Chuncheon Sacred Heart Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 283
• Est. completion date: December 31, 2021
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 24 Years to 82 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastrointestinal Microbiome
• Liver Disease Chronic
• Liver Diseases
• Sarcopenia

Intervention

Diagnostic Test:
• Sarcopenia_CT
measurement of skeletal muscle through abdominal computed tomography

Locations

Country	Name	City	State
Korea, Republic of	Department of Internal Medicine, Hallym University Medical College	Chuncheon	Gangwon-do

Sponsors (6)

Lead Sponsor	Collaborator
Chuncheon Sacred Heart Hospital	Dongtan Sacred Heart Hospital, Hallym University Medical Center, Hangang Sacred Heart Hospital, Kangdong Sacred Heart Hospital, Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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