A Study of the Intestinal Microbiome in Patients with Cirrhosis (IIT_MicroB)

January 29, 2025 updated by: Hye Won Lee, Yonsei University
This study aims to establish a cohort for analyzing the gut microbiome of patients with liver cirrhosis and to identify factors that influence the prognosis of these patients.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients visiting our hospital with liver cirrhosis

Description

Inclusion Criteria:

  1. Aged 19 years or older:
  2. Patients visiting the hospital with liver cirrhosis.
  3. Patients diagnosed with liver cirrhosis who can understand the information provided to them or their representatives and have voluntarily given written consent to participate in this study

Exclusion Criteria:

  1. Cases not meeting the inclusion criteria
  2. Patients who refuse participation
  3. Patients who have taken or been administered antibiotics within the past 2 weeks or are scheduled to take or receive antibiotics during the study period
  4. Cases where the diagnosis is unclear
  5. Cases with incomplete data or missing investigation items
  6. Individuals deemed unsuitable by the principal investigator for other reasons

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with cirrhosis
Other: Determine the gut microbiome at baseline and 12 months.
There is no separate treatment, surgery, or other intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence rate of non-targeted complications according to changes in the gut microbiome
Time Frame: baseline, Month 12
We observed changes in the gut microbiome of the subjects participating in the study at baseline and 12 months, and confirmed the incidence of non-target complications accordingly.
baseline, Month 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Liver cancer incidence rate according to gut microbiome composition
Time Frame: Baseline, 12 Month
We observed changes in the gut microbiome of the subjects participating in the study at baseline and 12 months, and confirmed the liver cancer incidence rate accordingly.
Baseline, 12 Month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2025

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

January 22, 2025

First Submitted That Met QC Criteria

January 29, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 29, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIT_MicroB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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