A Study of the Intestinal Microbiome in Patients with Cirrhosis

NCT06808698 | Not Yet Recruiting

• 1 other identifier: IIT_MicroB
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Liver Cirrhosis

Keywords

liver cirrhosis

Outcome Measures

Primary Outcomes (1)

• Incidence rate of non-targeted complications according to changes in the gut microbiome

  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 Outcomes (1)

• Liver cancer incidence rate according to gut microbiome composition

  Baseline, 12 Month

Study Arms (1)

Patients with cirrhosis

Patients with cirrhosis

Other: Determine the gut microbiome at baseline and 12 months.

Interventions

Determine the gut microbiome at baseline and 12 months. OTHER

There is no separate treatment, surgery, or other intervention.

Patients with cirrhosis

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients visiting our hospital with liver cirrhosis

You may qualify if:

• Aged 19 years or older:
• Patients visiting the hospital with liver cirrhosis.
• 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

You may not qualify if:

• Patients who refuse participation
• 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
• Cases where the diagnosis is unclear
• Cases with incomplete data or missing investigation items
• Individuals deemed unsuitable by the principal investigator for other reasons

Sponsors & Collaborators

• Yonsei University: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

EDTA 5ml, SST 5ml

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Hye Won Professor Lee

CONTACT

+822-2228-0813; lorry-lee@yuhs.ac

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD

Study Record Dates

• First Submitted: January 22, 2025
• First Posted: February 5, 2025
• Study Start: June 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 5, 2025

Record last verified: 2025-01