NCT05729269

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
283

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

March 22, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2019

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 6, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 15, 2023

Completed
Last Updated

February 15, 2023

Status Verified

April 1, 2021

Enrollment Period

2.1 years

First QC Date

February 6, 2023

Last Update Submit

February 6, 2023

Conditions

Gastrointestinal MicrobiomeSarcopeniaLiver Disease Chronic

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Chronic liver disease

non-alcohol liver disease, alcohol liver disease, liver cirrhosis

Diagnostic Test: Sarcopenia_CT

Interventions

Sarcopenia_CTDIAGNOSTIC_TEST

measurement of skeletal muscle through abdominal computed tomography

Chronic liver disease

Eligibility Criteria

Age24 Years - 82 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • \. 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Internal Medicine, Hallym University Medical College

Chuncheon, Gangwon-do, 24253, South Korea

Location

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2023

First Posted

February 15, 2023

Study Start

March 22, 2017

Primary Completion

April 30, 2019

Study Completion

December 31, 2021

Last Updated

February 15, 2023

Record last verified: 2021-04

Locations

KR(1)