A Study of the Intestinal Microbiome in Patients with Cirrhosis

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.

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Key information

Conditions

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

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Cases not meeting the inclusion criteria
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

Treatment and study plan

Determine the gut microbiome at baseline and 12 months.

Other

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

Primary outcomes

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.

Secondary outcomes

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hye Won Professor Lee

CONTACT

[email protected]

+822-2228-0813

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Acronym: IIT_MicroB

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Feb 5, 2025
Registry last updated: Feb 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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