Clinical study on the efficacy and safety of microecological agents in patients with chronic hepatitis B treated with LLV by nucleoside

Clinical research protocol on the efficacy and safety of microecological preparations in patients with chronic hepatitis B with low viral load after nucleoside drug treatment

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400088174

Enrollment

Unknown

Registered

2024-08-13

Start date

2024-09-01

Completion date

Unknown

Last updated

2024-08-19

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

Conditions

Hepatitis B

Interventions

Experimental group:Oral enterobacteria capsules, 15 capsules/times/day, once every other day, for two consecutive weeks every month for 6 months. The total dose is 45 capsules (about 60g).

Control group:The control group was treated with placebo, which was empty capsules, 15 capsules/times/day, once every other day, for two weeks a month for 6 months

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) 18 years old? patient age? 65 years old, gender is not limited; (2) Meet the diagnostic criteria for chronic hepatitis B in the Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2022 Edition); (3) Treated with nucleoside drugs entecavir, tenofovir, tenofovir alafenol or emitenofovir for at least 48 weeks, and the peripheral blood HBVDNA level meets the low viral load standard, that is, the HBVDNA level is 20-2000Iu/ml; (4) The subjects were voluntarily enrolled and could understand and sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Combined with hepatitis A, hepatitis C, hepatitis D, hepatitis E and/or HIV infection, or chronic liver disease caused by other reasons, such as alcoholic hepatitis, drug-induced hepatitis, autoimmune liver disease; (2) Pregnant or lactating women, or subjects with birth plans during the study period; (3) History of acute infection or antibiotic treatment in the past 3 months; (4) Those who take probiotics, gastrointestinal motility drugs, hypoglycemic drugs, lipid-lowering drugs and other drugs that may affect the intestinal flora; (5) There are tumors, immunocompromised diseases, etc; (6) Any other condition judged by the investigator to be unsuitable for this study.

Design outcomes

Primary

Measure	Time frame
HBV DNA negative conversion rate;	—

Secondary

Measure	Time frame
The magnitude of hepatitis B surface antigen decline;HBsAg negative conversion rate or serum conversion rate;HBeAg negative conversion rate or serum conversion rate;	—

Countries

China

Contacts

Public ContactPan Xiucheng

The Affiliated Hospital of Xuzhou Medical University

xzpxc68@126.com+86 180 5226 8129

Outcome results

None listed

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