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A Cross-sectional Study on the Association of Peptidoglycan Fragments Derived From Gut Microbiota With Alcohol Liver Disease

NCT ID: NCT07284862

Last Updated: 2025-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-07-01

Study Completion Date

2025-11-01

Brief Summary

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alcohol-associated liver disease (ALD) is a leading cause of cirrhosis, yet the role of gut microbiota-derived peptidoglycan (PG) metabolites in liver injury remains unclear. This study aimed to elucidate the role of microbial DL-endopeptidases, which generate NOD2 ligands, in modulating alcohol-induced liver injury.Participants will provide stool samples.

Detailed Description

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Conditions

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Alcohol-associated Liver Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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ALD-related cirrhosis

This cohort consists of patients with alcohol-related liver cirrhosis, diagnosed based on clinical-pathological assessment with confirmation by two hepatologists. All patients had chronic liver disease for ≥6 months with an established etiology (primarily alcohol-related, defined as \>2 oz/day ethanol for men or \>1 oz/day for women for \>10 years). Key exclusions include recent (within 1 month) use of antibiotics/probiotics/PPIs, recent (within 6 months) gastrointestinal procedures, and presence of uncontrolled infection or hypertension.

An observational, non-interventional study design.

Intervention Type OTHER

An observational, non-interventional study design.

health

This cohort consists of age- and sex-matched healthy controls recruited from a Health Checkup Center, with no clinically diagnosed chronic diseases.

An observational, non-interventional study design.

Intervention Type OTHER

An observational, non-interventional study design.

Interventions

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An observational, non-interventional study design.

An observational, non-interventional study design.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

(1) patients diagnosed with liver cirrhosis based on clinical-pathologic features including liver history and endoscopic or radiologic findings (the presence of clinical cirrhosis was adjudicated in a blinded fashion by two separate hepatology experts; to be included, both experts were required to agree on the presence of clinical cirrhosis) and (2) all patients with chronic liver disease were required to have evidence of clinical liver disease for at least 6 months and were required to have an identifiable etiology of liver disease, including alcohol-related liver diseases (based on a history of alcohol use disorder or a past history of alcohol consumption of greater than 2 ounces of ethanol per day for men or 1 ounce of ethanol per day for women (for greater than 10 years) with no other cause of liver disease identified), NAFLDs, viral hepatitis B or C (detected by HCV RNA or HBV DNA measurement) or autoimmune liver disease (based on international autoimmune scoring criteria).

Exclusion Criteria

(1) individuals treated with antibiotics, probiotics or proton pump inhibitors within 1 month before sample collection; (2) any participant undergoing a gastrointestinal surgical procedure or colonoscopy within 6 months before sample collection; (3) any individual with uncontrolled infection; and (4) individuals with uncontrolled systolic blood pressure.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Zhujiang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xiaolong He, xiaolong

Role: STUDY_DIRECTOR

Southern Medical University, China

Locations

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Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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ZhujingGS

Identifier Type: -

Identifier Source: org_study_id