Study on the mechanism of intestinal microecology influencing clinical cure of chronic hepatitis B

Exploring the efficacy and safety of fecal microbiota transplantation combined with PegIFN-a2b in hepatitis B e antigen-negative patients previously treated :a national multicenter, prospective cohort study

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400080986

Enrollment

Unknown

Registered

2024-02-20

Start date

2024-02-29

Completion date

Unknown

Last updated

2024-02-26

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

Conditions

chronic hepatitis B

Interventions

A Group:Fecal microbiota transplantation and PegIFN-a2b

B Group:Probiotics and PegIFN-a2b

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Age of 18-65 years old; (2) Oral NAs antiviral treatmen for at least 1 year; (3) Undetectable HBVDNA (< 30IU/ml), HBeAg negative, HBsAg < 1500IU/ml; (4) ALT < 2ULN (5) Written informed consent was obtained from all subjects (or their guardians). Note: Patients who had completed previous interferon therapy more than 2 years were eligible for enrollment.

Exclusion criteria

Exclusion criteria: (1) Acute infection or antibiotic treatment within the past 3 months; (2) Cirrhosis(Child-Pugh>5); (3) Genetic or metabolic liver disease, such as Wilson's disease or hemochromatosis; (4) Co-infection with hepatitis A virus, hepatitis C virus, hepatitis E virus, Epstein-Barr virus or cytomegalovirus; (5) Patients with symptoms and signs of HCC and AFP>100ng/ml were excluded, but if they had been cured more than 2 years, they could be enrolled. (6) Pregnant or lactating women; (7) Autoimmune diseases; (8) A history of mental illness (such as major depression); (9) Uncontrolled epilepsy, hypertension and diabetes; (10) Alcohol abuse; (11) Drug abuse; (12) Severe cardiovascular and cerebrovascular diseases; (13) Other evidence of organ transplantation or malignancy; (14) Any other condition that the investigator judged was not appropriate for the study.

Design outcomes

Primary

Measure	Time frame
HBsAg clearance rate at the end of treatment;	—

Secondary

Measure	Time frame
Adverse events related to FMT;Adverse events related to PegIFN-a2b;Incidence of HBsAg decline =90% at 36 weeks of treatment;The magnitude of HBsAg decline at the end of treatment;Incidence of HBs-Ab=100IU/L at the end of treatment;alterations in microbial diversity in fecal;	—

Countries

China

Contacts

Public ContactPengfei Zou

Shulan (Hangzhou) Hospital

474329859@qq.com+86 138 5811 5506

Outcome results

None listed

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