A prospective study of ursodeoxycholic acid combined with bifidobacterium therapy for chronic hepatitis B patients

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2200062861

Enrollment

Unknown

Registered

2022-08-21

Start date

2022-07-22

Completion date

Unknown

Last updated

2024-05-21

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

Conditions

Chronic hepatitis B

Interventions

experimental group:ursodeoxycholic acid combined with bifidobacterium

control group 1:ursodesoxycholic acid

control group 2:Bifidobacterium

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Males or females aged 18 to 65 years; 2. Chronic HBV infected patients based on diagnostic criteria of 2019 China clinical practice guidelines of chronic hepatitis B, who have indications for antiviral therapy but untreated; 3. The liver function is well compensated, and the Child-Paugh grade is A; 4. To be able to sign the informed consent and have good medical compliance.

Exclusion criteria

Exclusion criteria: 1. Complicated with HAV, HCV, HDV, HEV, HIV infection, or other chronic liver diseases such as alcoholic liver disease, genetic metabolic liver disease, drug-induced liver disease, non-alcoholic fatty liver disease; 2. Total bilirubin is higher than 2 times the normal range; 3. Combined with autoimmune diseases, including autoimmune liver diseases, psoriasis, etc.; 4. Patients with serious diseases of heart, lung, kidney, brain, blood and other important organs; 5. Patients with severe neurological and psychiatric diseases (such as epilepsy, depression, mania, seizures, schizophrenia, etc.); 6. Control unstable diabetes, hypertension, thyroid diseases, etc.; 7. Patients with a history of severe retinopathy or other evidence of retinopathy; 8. Drug abuse; 9. Pregnant or lactating women or patients who plan to become pregnant during the study and were unwilling to use contraception; 10. The researcher considers that the current condition of the subject is not suitable to participate in this study; 11. Patients participating in other clinical trials at the same time.

Design outcomes

Primary

Measure	Time frame
HBV DNA quantitation;liver function;serum HBsAg quantitation;serum HBeAg quantitation;	—

Secondary

Measure	Time frame
phenotype and function change of immunocyte;16S rRNA Sequencing for stool microotganism;	—

Countries

China

Contacts

Public ContactOu Qishui

The First Affiliated Hospital of Fujian Medical University

ouqishui@fjmu.edu.cn+86 591 8798 1909

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 5, 2026