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

NCT07284862 | Completed

• 1 other identifier: ZhujingGS
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alcohol-associated Liver Disease

Outcome Measures

Primary Outcomes (1)

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

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

  Baseline (pre-treatment)

Study Arms (2)

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.

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.

Other: An observational, non-interventional study design.

Interventions

An observational, non-interventional study design. OTHER

An observational, non-interventional study design.

ALD-related cirrhosis; health

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Meet eligibility criteria

You may qualify if:

• (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).

You may not qualify if:

• (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.

Sponsors & Collaborators

• Zhujiang Hospital: lead

Study Sites (1)

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, 510000, China

Location

Study Officials

• Xiaolong He, xiaolong

  Southern Medical University, China

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: December 16, 2025
• Study Start: July 1, 2025
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: December 16, 2025

Record last verified: 2025-11

Locations

CN (1)