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Effect of intestinal microbiota on clinical outcome of alcoholic liver disease and therapeutic effect by regulating microbiota

Effect of intestinal microbiota on clinical outcome of alcoholic liver disease and therapeutic effect by regulating microbiota

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000038216
Enrollment
Unknown
Registered
2020-09-14
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-11-30

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

Conditions

Alcoholic liver diease

Interventions

Alcoholic cirrhosis (compensated stage):Nil
Severe alcoholic hepatitis:Nil
Healthy control group:Nil

Sponsors

Beijing Ditan Hospital,Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Part I: A. Patients with alcoholic cirrhosis (compensated stage) in the experimental group: 1. Patients with alcoholic cirrhosis diagnosed in our hospital were selected, and the diagnosis met the diagnostic criteria of China's guidelines for diagnosis and Treatment of Alcohol-related Liver Disease in 2018: they had A long history of drinking (generally over 5 years, the equivalent amount of alcohol was >= 40g/d for males and >= 20g/d for females). Imaging showed signs of cirrhosis (such as non-smooth surface, reduced liver volume and enlarged spleen); or the instantaneous elastic imaging value is greater than 12.5 kPa). 2. Patients in the compensatory period of liver function (child-pugh score is grade A or B) can understand and sign written informed consent, and voluntarily participate in this study. 3. Age 18-70 years old. B. Patients with severe alcoholic hepatitis: 1. The diagnosis of severe alcoholic hepatitis conforms to the diagnostic criteria of China's guideline for diagnosis and Treatment of Alcohol-related Liver Diseases in 2018: having a long history of alcohol consumption (generally over 5 years, equivalent alcohol volume >= 40g/d for male and >= 20g/d for female); There is a basis for alcoholic hepatitis (sudden onset or worsening of jaundice, such as serum bilirubin levels exceeding 3 times the normal upper limit; The -glutamyl transferase (GGT) level was significantly increased at the AST/ALT ratio of > 1.51. 2. Alcoholic hepatitis patients with liver failure performance, such as jaundice rapid deepening, coagulation mechanism disorders (PTA less than 40%), hepatic encephalopathy, renal failure, upper gastrointestinal bleeding, etc. Or Maddrey Discriminant Function (MDF) score >= 32. C. Healthy control group: selected healthy people matched with age, sex, BMI and other factors as the control group. Health control inclusion criteria: meeting the world Health Organization definition of health (i.e. in good physical, mental and social condition), no abnormal liver function test, and no history of alcohol consumption. Part II 1. Patients with severe alcoholic hepatitis: used to provide fecal bacteria. The admission and discharge criteria are the same as part I. 2. Fecal bacteria donors should be healthy persons. In addition to meeting the admission criteria of the first part of healthy persons, Fecal Microbiota donors should meet the requirements in the literature (Fecal Microbiota: An Update on Clinical Practice Clin Endosc 2019 52:137-143) and should be obviated by age 65 years old, BMI > 30 kg/m2, generation x syndrome, moderately severe malnutrition, last 6 months with antimicrobials, 3-6 months have diarrhoea, recently there have been difficult clostridium colitis, immune disorders or used immunosuppressant, intravenous drug use, or have the risk of HIV infection, nearly three months to overheating with tourism, chronic gastroenteritis, or other gastrointestinal diseases, autoimmune diseases, chronic pain syndrome, chronic fatigue, a comprehensive or nerve mental problems, etc.

Exclusion criteria

Exclusion criteria: 1. Patients with cirrhosis caused by other reasons except hepatitis B, Hepatitis C, drugs and autoimmunity; 2. Patients with primary liver cancer; 3. Patients who received anti-fungal or anti-bacterial drugs or oral intestinal microecological preparations within 1 month; 4. Patients with bacterial and fungal infection within 1 month; 5. Patients with human immunodeficiency virus infection; 6. Other patients with digestive tract diseases that may affect the intestinal microecology; 7. Uncontrolled kidney, heart, lung, vascular, neurologic, digestive (pancreatitis or pancreatic cancer), metabolic diseases (diabetes, thyroid disease and adrenal disease), immunodeficiency disease or cancer; 8. Persons with substance abuse or a history of substance abuse; 9. Pet-pregnant and lactating women; 10. The attending researchers determined that patients could not comply with the study's requirements.

Design outcomes

Primary

MeasureTime frame
liver function;LPS;Lactic acid;IL-2;IL-6;IL-8;Intestinal mucosal barrier function;Abundance of intestinal flora;Composition of intestinal flora;Immunohistochemistry of liver tissue;Immunohistochemistry of intestinal tissue;a MDR;

Secondary

MeasureTime frame
MDF;Child-pugh Score;MELD score;

Countries

China

Contacts

Public ContactHuichun Xing

Beijing Ditan Hospital, Capital Medical University

hchxing@sohu.com+86 13691143164

Outcome results

None listed

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