Cholestatic Liver Disease
Conditions
Interventions
Placebo Group:Application of Placebo-Controlled Therapy Combined with Ursodeoxycholic Acid Capsules
Probiotic Group:Application of Probiotics Combined with Ursodeoxycholic Acid Capsules
Sponsors
The Second Affiliated Hospital of the Army Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18–65 years (inclusive of the cut-off values), regardless of gender; 2.Meeting the diagnostic criteria for cholestatic liver disease recommended in the Guidelines for the Management of Cholestatic Liver Disease (2021) (i.e., ALP > 1.5 times the upper limit of normal [ULN] and GGT > 3 times the ULN); 3.For female subjects of childbearing age, the pregnancy test must be negative during the screening period, and they must use highly effective contraceptive measures from the screening period to 3 months after the last dose; male subjects whose partners are of childbearing age must use highly effective contraceptive measures from the first dose to 3 months after the last dose of the study drug; 4.Subjects must be able to understand the procedures of this study, be willing to comply with the clinical study protocol to complete the study, and sign the informed consent form;
Exclusion criteria
Exclusion criteria: 1.Having used probiotic preparations within 14 days before enrollment; 2.Suffering from chronic infections (e.g., hepatitis A, hepatitis B, tuberculosis, HIV infection); 3.Patients with clinically significant decompensated liver function (e.g., history of liver transplantation/waiting for liver transplantation, liver cirrhosis/complications of portal hypertension, hepatorenal syndrome, etc.); 4.Patients with hereditary hyperbilirubinemia or hemolytic diseases; 5.Patients with complete biliary obstruction; 6.Patients with pruritus caused by other factors such as allergic diseases; 7.Diseases that may cause non-hepatic elevation of ALP (e.g., Paget's disease) or diseases that may result in an expected life span of < 2 years (e.g., liver cancer, pancreatic cancer, cholangiocarcinoma, ampullary cancer, etc.); 8.Evidence of any other unstable or untreated clinically significant immune, endocrine, hematological, gastrointestinal, neurological, or psychiatric diseases as assessed by the investigator; 9.Having taken multiple drugs for disease treatment within 14 days before enrollment, such as antibacterial agents, antacids, bismuth preparations, tannic acid, medicinal charcoal, and tinctures; 10.Having a history of alcohol or drug abuse; 11.Female patients who are pregnant, planning to become pregnant, or lactating; 12.Patients who are currently participating in or planning to participate in other interventional clinical trials and have used study drugs; 13.Subjects who, in the investigator's judgment, cannot comply with the study procedures, or are deemed unsuitable for participation in this study for other reasons;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in GGT from baseline after 4 weeks of treatment; | — |
Countries
China
Contacts
Public ContactTang Bo
The Second Affiliated Hospital of the Army Medical University
Outcome results
None listed