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Completed

NCT Number: NCT07284862

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, 510000, China

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

An observational, non-interventional study design.

Other

An observational, non-interventional study design.

Primary outcomes

  1. Fecal NOD2-stimulating activity, measured using a HEK-Blue-hNOD2 reporter cell assay.

    Time frame: Baseline (pre-treatment)

    To explore the potential of peptidoglycan fragments as screening or diagnostic biomarkers for alcohol-related liver disease.

Sponsors and collaborators

Lead sponsor

Zhujiang Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 16, 2025
Registry last updated
Dec 16, 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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