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The multi-omics analysis reveals the impact of gut microbiota on host metabolism in alcohol-associated liver disease

The multi-omics analysis reveals the impact of gut microbiota on host metabolism in alcohol-associated liver disease

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500104209
Enrollment
Unknown
Registered
2025-06-12
Start date
2022-10-01
Completion date
Unknown
Last updated
2025-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol-associated liver disease

Interventions

Alcoholics without ALD group:None
Alcoholic fatty liver group:None
Alcoholic hepatitis group:None
Alcoholic cirrhosis group:None
Healthy control group:None

Sponsors

The Second Affiliated Hospital of Hainan Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Non-ALD alcoholics (1) The experimental group was selected as non-ALD addicts diagnosed in the outpatient clinic of our hospital, which refers to those who have a history of long-term excessive alcohol consumption (reaching or exceeding the risk threshold of ALD) but have not yet shown clear evidence of alcoholic liver injury; (2) The patient can understand and sign the written informed consent and voluntarily join this study; (3) Age 18-65 years old; 2. Alcoholic fatty liver disease (1) The experimental group selected the patients with alcoholic fatty liver disease diagnosed in the outpatient clinic of our hospital, and the diagnosis met the diagnostic criteria of the 2018 Chinese "Guidelines for the Diagnosis and Treatment of Alcohol-related Liver Disease": a history of long-term alcohol consumption (generally more than 5 years, equivalent to ethanol > = 40g/d for males and > for females = 20 g/d) only signs of fatty liver on imaging; (2) The patient can understand and sign the written informed consent and voluntarily join this study; (3) Age 18-65 years old; 3. Alcoholic hepatitis (1) The diagnosis meets the diagnostic criteria of the 2018 Guidelines for the Diagnosis and Treatment of Alcohol-related Liver Diseases in China: a history of long-term alcohol consumption (generally more than 5 years, equivalent to ethanol for men> = 40g/d, > for women =20g/d); Has an underlying alcoholic hepatitis (sudden onset or worsening of jaundice, eg, serum bilirubin levels greater than 3 times the upper limit of normal; The ratio of aspartate aminotransferase/alanine aminotransferase (AST/ALT) was > 1.5:1, and the level of ? ?-glutamyl transferase (GGT) was significantly increased. (2) Patients with severe alcoholic hepatitis have manifestations of liver failure, such as rapid deepening of jaundice, coagulation mechanism disorders (PTA less than 40%), hepatic encephalopathy, renal failure, upper gastrointestinal bleeding, etc., or Maddrey discriminant function (MDF) score >= 32 points; (3) The patient can understand and sign the written informed consent and voluntarily join the study; (4) Age 18-65 years old; 4. Patients with alcoholic cirrhosis (compensated phase) (1) The experimental group was selected from patients with alcoholic cirrhosis diagnosed in our hospital, and the diagnosis met the diagnostic criteria of the 2018 Guidelines for the Diagnosis and Treatment of Alcohol-related Liver Diseases in China: a history of long-term alcohol consumption (generally more than 5 years, equivalent to ethanol for males>= 40g/d, females >). = 20g/d) with signs of liver cirrhosis (e.g., unsmooth surface, reduced liver volume, splenomegaly) on imaging; or transient elastography value greater than 12.5 kPa); (2) compensatory phase of liver function (Child-pugh score of grade A or B); (3) The patient can understand and sign the written informed consent and voluntarily join the study; (4) Age 18-65 years old; 5. Healthy control group At the same time, healthy people with age, gender, BMI and other factors were selected as controls, and the enrollment criteria of healthy control were as follows: meeting the World Health Organization's definition of health (i.e., being in good physical, mental and social condition), no abnormal liver function tests, and no history of alcohol consumption.

Exclusion criteria

Exclusion criteria: 1. Age less than 18 years old; 2. Patients with severe organic diseases, malignant tumors, and autoimmune diseases of the gastrointestinal tract, cardiovascular, respiratory, kidney, thyroid and other systems; 3. Pregnant and lactating females; 4. The patient has recently used drugs; 5. Acute large-scale cerebral infarction, gastrointestinal hemorrhage, acute coronary syndrome, etc., and there is an acute stress state of the body; 6. Family or personal addiction to tobacco and alcohol, drug dependence, mental and psychological diseases, history of genetic diseases and infectious diseases, history of monogenic diseases or severe allergies, color blindness, color weakness, malnutrition, metal implants in the body, etc.

Design outcomes

Primary

MeasureTime frame
Liver function and blood lipids;Fecal microbiota metagenome;Fecal Fungal ITS;Plasma untargeted metabolomics;Fecal Targeted Short-Chain Fatty Acids (SCFAs);

Countries

China

Contacts

Public ContactFeihu Bai

The Second Affiliated Hospital of Hainan Medical University

baifeihu_hy@163.com+86 898 6680 2026

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026