Exploring gut microbiota changes in patients with alcohol-related liver disease

Alterations of Gut Microbiota and Metabolites in Asian Patients With Alcohol-associated Liver Disease

This study looks at how the bacteria in the gut change in people with alcohol-related liver disease to see if these changes are linked to the disease's progression and could help find new treatments.

Quick facts

• Study type: Observational
• Enrollment: 200 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Wuhan Union Hospital, China (Academic / other)
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT05448144 on ClinicalTrials.gov

What this trial studies

This observational study investigates the alterations in gut microbiota and metabolites among patients with alcohol-associated liver disease (ALD). It aims to map these changes across different stages of ALD, from asymptomatic liver steatosis to more severe conditions like alcoholic cirrhosis. By collecting stool and blood samples, the study seeks to understand the relationship between gut microbiota and the progression of ALD, potentially identifying new therapeutic targets. The findings could provide insights into the mechanisms underlying ALD and inform future treatment strategies.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 with a history of chronic heavy alcohol consumption and diagnosed with alcohol-associated liver disease.

Not a fit: Patients with hepatocellular carcinoma or other infectious liver diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to new therapeutic approaches for managing alcohol-related liver disease.

How similar studies have performed: While the relationship between gut microbiota and liver disease is being explored, this specific approach to mapping alterations in ALD is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. The group of ALD:

1. aged \>18 years;
2. patients who meet the diagnostic criteria of ALD in Chinese Guideline for the Prevention and Management of Alcoholic Liver Disease (2018 Update);
3. history of chronic heavy alcohol consumption;
4. with relatively complete clinical data and good compliance.

2. The group of purely drinking:

1. aged \>18 years;
2. history of chronic alcohol consumption;
3. no evidence of fatty liver, hepatitis or liver injury.

3. The group of healthy control:

1. aged \>18 years;
2. without history of alcohol consumption;
3. no evidence of fatty liver, hepatitis or liver injury.

Exclusion Criteria:

1. with hepatocellular carcinoma or hepatic metastases;
2. combined with infectious liver diseases, such as hepatitis A virus, hepatitis B virus, hepatitis C virus, hepatitis D virus, hepatitis E virus and human immunodeficiency virus (HIV);
3. combined with non-infectious liver diseases, such as non-alcoholic fatty liver disease, drug-induced hepatitis, autoimmune liver disease, Immunoglobulin G subclass 4-related liver disease, Wilson's disease, alpha 1-antitrypsin deficiency, Budd-Chiari syndrome, and other congenital liver diseases;
4. combined with severe organic lesions of other organs;
5. pregnant and lactating women.

Where this trial is running

Wuhan, Hubei

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)

Study contacts

• Study coordinator: Huikuan Chu, M.D.

Conditions Liver Disease; Alcohol-Related; Gut Microbiota; Alcohol-associated liver disease; Gut microbiota; Metabonomics